Philips Medical Systems (Cleveland) Inc - Philips Brilliance Big Bore Radiology CT - Class 2 Recall
Brilliance Big Bore Radiology CT (Model No. 728244) software version 4.2.0 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 1, 2018 Category: Medical Devices Source Type: alerts

Agfa Healthcare NV - Enterprise Imaging Desktops - Class 2 Recall
Enterprise Imaging Desktops Enterprise Imaging Desktops (Radiology Suite/Cardiology Suite) when deployed as a departmental Picture Archiving and Communications System (PACS) provides an interface for the acquisition, display, digital processing, annotation, review, printing, storage and distribution of multimodality medical images, reports and demographic information for diagnostic purposes within the system and across computer networks. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 12, 2018 Category: Medical Devices Source Type: alerts

Agfa Healthcare NV - Agfa DXD 600 system - Class 2 Recall
DX-D 600 Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system used in hospitals, clinics and medical practices by physicists, radiographers and radiologists to make, process and view static X-Ray radiographic images of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts on adult, pediatric or neonatal patients. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 26, 2018 Category: Medical Devices Source Type: alerts

Medtronic Navigation, Inc. - Visualase Cooled Laser Applicator System - Class 2 Recall
Visualase Cooled Laser Applicator System (VCLAS) labeled as: a. Part Number 9735559, Visualase¿ Cooled Laser Applicator System 3mm Tip; b. Part Number 9735560 Visualase¿ Cooled Laser Applicator System 10mm Tip; c. Part Number 9735561 Visualase¿ Cooled Laser Applicator System 15mm Tip Product Usage: The Visualase Thermal Therapy System is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy under magnetic resonance imaging (MRI) guidance in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels in the pericardi...
Source: Medical Device Recalls - July 20, 2018 Category: Medical Devices Source Type: alerts

Philips Medical Systems (Cleveland) Inc - Philips Brilliance Big Bore Radiology 728244 - Class 2 Recall
Brilliance Big Bore Radiology 728244 (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 23, 2018 Category: Medical Devices Source Type: alerts

Siemens Medical Solutions USA, Inc. - Biograph mCT Systems: - Class 2 Recall
Biograph mCT Systems: (a) Biograph mCT S(64)-3R, Material Number 10248669 Product Usage: The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals...
Source: Medical Device Recalls - June 9, 2018 Category: Medical Devices Source Type: alerts

GE Healthcare - Centricity Universal Viewer - Class 2 Recall
Centricity Universal Viewer Product Usage: Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Megapixel resolution and meet other technical specifications reviewed an...
Source: Medical Device Recalls - June 7, 2018 Category: Medical Devices Source Type: alerts

GE Healthcare - Centricity PACSIW with Universal Viewer - Class 2 Recall
Centricity PACS-IW with Universal Viewer Product Usage: Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Megapixel resolution and meet other technical specification...
Source: Medical Device Recalls - June 7, 2018 Category: Medical Devices Source Type: alerts

Visaris DOO - Vision (Vision C, Vision U, and Vision V) - Class 2 Recall
Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.2 The Vision systems are intended for use in all areas of diagnostic radiography imaging and specifically at secondary and tertiary levels of medical care. Powerful positioning capability makes this system particularly suited for institutions with immobile or hardly mobile patients, such as trauma wards and emergency departments. The system s versatility also makes it suitable for unified diagnostic imaging services for medium size hospitals where this system can cover all diagnostic radiography needs. In general, Vision systems are intended to positi...
Source: Medical Device Recalls - May 16, 2018 Category: Medical Devices Source Type: alerts

Visaris DOO - Vision (Vision C, Vision U, and Vision V) - Class 2 Recall
Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.3 The Vision systems are intended for use in all areas of diagnostic radiography imaging and specifically at secondary and tertiary levels of medical care. Powerful positioning capability makes this system particularly suited for institutions with immobile or hardly mobile patients, such as trauma wards and emergency departments. The system s versatility also makes it suitable for unified diagnostic imaging services for medium size hospitals where this system can cover all diagnostic radiography needs. In general, Vision systems are intended to positi...
Source: Medical Device Recalls - May 16, 2018 Category: Medical Devices Source Type: alerts

Visaris DOO - Vision (Vision C, Vision U, and Vision V) - Class 2 Recall
Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.4 The Vision systems are intended for use in all areas of diagnostic radiography imaging and specifically at secondary and tertiary levels of medical care. Powerful positioning capability makes this system particularly suited for institutions with immobile or hardly mobile patients, such as trauma wards and emergency departments. The system s versatility also makes it suitable for unified diagnostic imaging services for medium size hospitals where this system can cover all diagnostic radiography needs. In general, Vision systems are intended to positi...
Source: Medical Device Recalls - May 16, 2018 Category: Medical Devices Source Type: alerts

Invivo Corporation - PHILIPS Xper Flex Cardio Physiomonitoring System - Class 2 Recall
PHILIPS Xper Flex Cardio Physiomonitoring System, Model Numbers: 453564241901, 453564483321, 453564621791, and 989803199561 (international only) The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular, disease when non-invasive indicators warrant such. Its users, responsible to interpret the data made available, will be professional health care providers, such as physicians, registered nurses, cardiovascular technicians, radiology technicians, and other clinical health care providers. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 15, 2018 Category: Medical Devices Source Type: alerts

Siemens Medical Solutions USA, Inc - Syngo Plaza - Class 2 Recall
Syngo.plaza software VB10A model numbers: 10863171, 10863172, 10863173 Syngo.Plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo.plaza also supports storage and archiving of DICOM Structured reports. In a comprehensive imaging syngo.plaza integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer specific workflows. Syngo.plaza optionally uses a variety of advanced postprocessing applications. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 8, 2018 Category: Medical Devices Source Type: alerts

Siemens Medical Solutions USA, Inc - Syngo Plaza - Class 2 Recall
Syngo.plaza software Syngo.Plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo.plaza also supports storage and archiving of DICOM Structured reports. In a comprehensive imaging syngo.plaza integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer specific workflows. Syngo.plaza optionally uses a variety of advanced postprocessing applications. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 8, 2018 Category: Medical Devices Source Type: alerts

Philips Medical Systems (Cleveland) Inc - Philips Healthcare Brilliance Big Bore (Radiology) - Class 2 Recall
Brilliance Big Bore (Radiology) - Model no. 728244, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 18, 2018 Category: Medical Devices Source Type: alerts

Philips Medical Systems (Cleveland) Inc - Brilliance Big Bore Radiology CT - Class 2 Recall
Brilliance Big Bore Radiology CT with 4.2.0 software version. Model #' 728244 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 3, 2018 Category: Medical Devices Source Type: alerts

Siemens Medical Solutions USA, Inc - Syngo.plaza - Class 2 Recall
Syngo.plaza systems with SW VB20A, Model Number - 10863171, 10863172, 10863173 Product Usage: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo.plaza also supports storage and archiving of DICOM Structured reports. In a comprehensive imaging syngo.plaza integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer specific workflows. Syngo.plaza optionally uses a variety of advanced postprocessing applications. (...
Source: Medical Device Recalls - February 6, 2018 Category: Medical Devices Source Type: alerts

Siemens Medical Solutions USA, Inc - Syngo.plaza Picture Archiving and Communication System - Class 2 Recall
Syngo.plaza Picture Archiving and Communication System (PACS) with software version VB20A; Model numbers: 10863171, 10863172, 10863173 Syngo.plaza is a Picture Archiving and Communication System (PACS) software device intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo.plaza also supports storage and archiving of DICOM Structured reports. In a comprehensive imaging syngo.plaza integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer specific workflows. Syngo.plaza optionally ...
Source: Medical Device Recalls - February 1, 2018 Category: Medical Devices Source Type: alerts

Siemens Medical Solutions USA, Inc - Syngo.plaza - Class 2 Recall
Syngo.plaza, Picture Archiving and Communications System(PACS), Model 10863171 Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo.plaza also supports storage and archiving of DICOM Structured reports. In a comprehensive imaging syngo.plaza integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer specific work flows. Syngo.plaza optionally uses a variety of advanced postprocessing applications. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 22, 2017 Category: Medical Devices Source Type: alerts

Siemens Medical Solutions USA, Inc. - Symbia Intevo 16 - Class 2 Recall
Symbia Intevo 16, SPECT/CT System, Emission Computed Tomography System To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV. SPECT: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV. CT: The CT component is intended to produce cross sectional images of the body by computer reconstruction of x-ray transmission data from either...
Source: Medical Device Recalls - November 17, 2017 Category: Medical Devices Source Type: alerts

Siemens Medical Solutions USA, Inc. - Symbia Intevo 6 - Class 2 Recall
Symbia Intevo 6, SPECT/CT System, Emission Computed Tomography System To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV. SPECT: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV. CT: The CT component is intended to produce cross sectional images of the body by computer reconstruction of x-ray transmission data from either ...
Source: Medical Device Recalls - November 17, 2017 Category: Medical Devices Source Type: alerts

Invivo Corporation - Flex Cardio Patient Monitoring System - Class 2 Recall
Xper Flex Cardio PhysioMonitoring system The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular disease when non-invasive indicators warrant such. Its users, responsible to interpret the data made available, will be professional health care providers, such as physicians, registered nurses, cardiovascular technicians, radiology technicians, and other clinical health care providers. The Xper Flex Cardio physiomonitoring system may be used to display and analyze surface ECG (electrocardiogram), respiration, invasive pressure, Sp02 (Pulse Oximetry), End Tidal C02 (carbon...
Source: Medical Device Recalls - November 10, 2017 Category: Medical Devices Source Type: alerts

Siemens Medical Solutions USA, Inc. - 18L6HD transducer - Class 2 Recall
18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer 10041227 & 10789400 S1000 10441701 S2000 10041461 S2000 (Refurb) - 10440017 S3000 10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 25, 2017 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA, Inc - Syngo.via Picture archiving and communication system - Class 2 Recall
Syngo.via, Picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a standalone device or together with a variety of cleared and unmodified syngo based software options. Syngo.via supports interpretation and evaluation of examinations within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments. The system is not intended for the displaying of digital mammography images for diagnosis in the U.S. The system is a software only medical device. It defines ...
Source: Medical Device Recalls - March 28, 2017 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA, Inc - Syngo.x Picture archiving and communication system - Class 2 Recall
Syngo.x, Picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a standalone device or together with a variety of cleared and unmodified syngo based software options. Syngo.via supports interpretation and evaluation of examinations within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments. The system is not intended for the displaying of digital mammography images for diagnosis in the U.S. The system is a software only medical device. It defines mi...
Source: Medical Device Recalls - March 28, 2017 Category: Medical Equipment Source Type: alerts

Philips Medical Systems (Cleveland) Inc - Brilliance BigBore Radiology CT - Class 2 Recall
Brilliance BigBore Radiology CT - 728244 Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories. This information may be used by a trained healthcare professional as a diagnostic tool for the visualization and analysis of anatomical and pathological structures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 21, 2017 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA, Inc - Syngo.plaza Picture Archiving and communications systems - Class 2 Recall
Syngo.plaza, Picture Archiving and Communications System (PACS) Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo.plaza also supports storage and archiving of DICOM Structured reports. In a comprehensive imaging syngo.plaza integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer specific workflows. Syngo.plaza optionally uses a variety of advanced postprocessing applications (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 11, 2017 Category: Medical Equipment Source Type: alerts

Mckesson Medical Imaging - McKesson Radiology 12.2 Picture Archive Communication System (PACS) - Class 2 Recall
McKesson Radiology 12.2 - Picture Archive Communication System (PACS) (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 3, 2017 Category: Medical Equipment Source Type: alerts

Villa Radiology Systems LLC - Apollo - Class 2 Recall
Apollo: Models: 9784000131, 9784000231, 9784020131, 9784020231, 9784100231, 9784120131, 9784120231, 9784130131 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 21, 2017 Category: Medical Equipment Source Type: alerts

Villa Radiology Systems LLC - Apollo DRF - Class 2 Recall
Apollo DRF: Model: 9784220831 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 21, 2017 Category: Medical Equipment Source Type: alerts

Villa Radiology Systems LLC - Apollo EZ - Class 2 Recall
Apollo EZ: Model: 9784152036 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 21, 2017 Category: Medical Equipment Source Type: alerts

Villa Radiology Systems LLC - Juno DRF - Class 2 Recall
Juno DRF; Model: 709020 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 21, 2017 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA Inc. - Biograph mCT S(64)4R - Class 2 Recall
Biograph mCT S(64)-4R, Material Number 10248672 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining...
Source: Medical Device Recalls - January 11, 2017 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA Inc. - BIOGRAPH mCT 20 Excel - Class 2 Recall
BIOGRAPH mCT 20 Excel, Material Number 10507786 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining...
Source: Medical Device Recalls - January 11, 2017 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA Inc. - Bio mCTS(40) 3R4R Upgrade - Class 2 Recall
Bio mCT-S(40) 3R->4R Upgrade, Material Number 10250743 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of d...
Source: Medical Device Recalls - January 11, 2017 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA Inc. - Biograph mCT Flow 404R - Class 2 Recall
Biograph mCT Flow 40-4R, Material Number 10529159 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determini...
Source: Medical Device Recalls - January 11, 2017 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA Inc. - Biograph mCT X3R - Class 2 Recall
Biograph mCT X-3R, Material Number 10248673 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining var...
Source: Medical Device Recalls - January 11, 2017 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA Inc. - Biograph mCT Flow Edge4R - Class 2 Recall
Biograph mCT Flow Edge-4R, Material Number 10528955 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determi...
Source: Medical Device Recalls - January 11, 2017 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA Inc. - Biograph mCT X4R - Class 2 Recall
Biograph mCT X-4R, Material Number 10248670 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining var...
Source: Medical Device Recalls - January 11, 2017 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA Inc. - Biograph mCT S(40)4R - Class 2 Recall
Biograph mCT S(40)-4R, Material Number 10248671 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining...
Source: Medical Device Recalls - January 11, 2017 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA Inc. - Biograph mCT S(64)3R - Class 2 Recall
Biograph mCT S(64)-3R, Material Number 10248669 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining...
Source: Medical Device Recalls - January 11, 2017 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA Inc. - Biograph mCT S(40)3R - Class 2 Recall
Biograph mCT S(40)-3R, Material Number 10248668 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining...
Source: Medical Device Recalls - January 11, 2017 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA Inc. - Biograph mCTX w/TrueV Upgrade - Class 2 Recall
Biograph mCT-X w/TrueV Upgrade, Material Number 10250745 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of de...
Source: Medical Device Recalls - January 11, 2017 Category: Medical Equipment Source Type: alerts

Varian Medical Systems, Inc. - Eclipse Treatment Planning System version 13.MR2 - Class 2 Recall
Eclipse Treatment Planning System version 13.MR2 [13.06.31 with Smart Segmentation Knowledge Based Contouring version 2.3 [2.3.12] Radiology: The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 11, 2017 Category: Medical Equipment Source Type: alerts

Accuray Incorporated - CyberKnife Robotic Radiosurgery Systems - Class 2 Recall
CyberKnife Robotic Radiosurgery Systems, models: G3, G4, VSI. Radiology: The CyberKnife Robotic Radiosurgery System is indicated for treatment planning and image guided stereotactic Radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 22, 2016 Category: Medical Equipment Source Type: alerts

Accuray Incorporated - CyberKnife Robotic Radiosurgery System - Class 2 Recall
CyberKnife Robotic Radiosurgery System using software version 10.6; Catalog/Part Number: 54000 UDI: M658053301 0 Radiology: The CyberKnife Robotic Radiosurgery System is indicated for treatment planning and image guided stereotactic Radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 13, 2016 Category: Medical Equipment Source Type: alerts

Merge Healthcare, Inc. - eFilm Workstation - Class 2 Recall
Merge, eFilm Workstation and eFilm Lite eFilm Workstation with Modules is a software application that is used for viewing medical images. eFilm Workstation with Modules receives digital images and data from various sources (including but not limited to CT, MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources). eFilm Workstation with Modules can be used to communicate, process and display medical images. Users have access to various image processing and measurement tools to assist them in viewing images. In addition, users can overlay templates ...
Source: Medical Device Recalls - December 6, 2016 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA, Inc. - ACUSON SC2000 - Class 2 Recall
Z6Ms transesophageal transducers used on ACUSON SC2000 ultrasound systems, Z6Ms model 10436113. Radiology: The ACUSON SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Neurological-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctive with other medical d...
Source: Medical Device Recalls - November 29, 2016 Category: Medical Equipment Source Type: alerts

Merge Healthcare, Inc. - RadSuite (by Merge Healthcare) - Class 2 Recall
Merge RadSuite,f/k/a: Emageon Advanced Visualization , RadSuite versions 8.30.7.8, 8.30.7.9, 8.30.8, and 8.31. Advanced Visualization (Image Viewing) includes: Full featured 2D imaging, 3D surface and volume rendering, Real-time Multi-Planar Reformatting (MPR), Real-time oblique imaging, Integrated image fusion, JPEG2000-based Adaptive Bandwidth Streaming, JPEG and Key Image Note export, Presentation States, Annotation and measurement tools, Automated linking, Display protocols, Enterprise Worklist, prior study management, softcopy viewing of digital mammography images provided that only 5 MP monitors with a cleared 510(k)...
Source: Medical Device Recalls - November 19, 2016 Category: Medical Equipment Source Type: alerts

Mckesson Medical Imaging Group - McKesson Radiology (MR) Picture Archive Communication System (PACS) - Class 2 Recall
McKesson Radiology McKesson Radiology (MR) is a Picture Archiving Communication System (PACS). It is a medical image and information management application that is intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical imaging systems. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 23, 2016 Category: Medical Equipment Source Type: alerts