Navilyst Medical, Inc - NAMIC (TM) Convenience Kit - Class 2 Recall
NAMIC Convenience Kit, RADIOLOGY KIT, UPN H749601014911, REF/Catalog No. 60101491, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136683. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 27, 2015 Category: Medical Equipment Source Type: alerts
Navilyst Medical, Inc - NAMIC (TM) Convenience Kit - Class 2 Recall
NAMIC Convenience Kit, RADIOLOGY KIT, UPN H749601506921, REF/Catalog No. 60150692, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 27, 2015 Category: Medical Equipment Source Type: alerts
Navilyst Medical, Inc - NAMIC (TM) Convenience Kit - Class 2 Recall
NAMIC Convenience Kit, RADIOLOGY KIT, UPN H7496002072111, REF/Catalog No. 600207211, STERILE, Rx ONLY --- For single use only. Device Listing Number D136683. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 27, 2015 Category: Medical Equipment Source Type: alerts
Navilyst Medical, Inc - NAMIC (TM) Convenience Kit - Class 2 Recall
NAMIC Convenience Kit, RADIOLOGY KIT, UPN H749600617521, REF/Catalog No. 60061752, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136683. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 27, 2015 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA, Inc. - Siemens Symbia T series - Class 2 Recall
The Siemens Symbia T series is intended to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 11, 2015 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA, Inc. - Siemens Symbia S series - Class 2 Recall
The Siemens Symbia S series is intended to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 11, 2015 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA, Inc - Syngo.plaza - Class 2 Recall
Syngo.plaza: 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 - January 29, 2015 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA, Inc. - Symbia Intevo Excel - Class 2 Recall
The Symbia Intevo Excel is a non-diagnostic SPECT ICT system with CT support for only attenuation correction and anatomical localization. The Symbia Intevo Series are xSPECT systems. These are SPECT and T systems integrated through xSPECT technology during image registration and reconstruction. This xSPECT integration enables the use of extra-modal information for high image quality and quantification. The Siemens Symbia series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for t...
Source: Medical Device Recalls - January 7, 2015 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA, Inc. - Symbia T Series - Class 2 Recall
The Siemens Symbia T series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures. SPECT: The SPECT component is intended to detect or image the distribution of radionuclides in the body or organ (physiology), us...
Source: Medical Device Recalls - January 7, 2015 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA, Inc. - Symbia S Series - Class 2 Recall
The Siemens Symbia S series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures. SPECT: The SPECT component is intended to detect or image the distribution of radionuclides in the body or organ (physiology), us...
Source: Medical Device Recalls - January 7, 2015 Category: Medical Equipment Source Type: alerts
Philips Medical Systems (Cleveland) Inc - Philips Brilliance CT Big Bore Oncology and Philips Brilliance CT Big Bore Radiology - Class 2 Recall
Brilliance CT Big Bore Oncology Whole Body Computed Tomography X-Ray System & Brilliance CT Big Bore Radiology Whole Body Computed Tomography X-Ray System. Product Usage: The Brilliance CT Big Bore is a Whole Body Computed Tomography X-Ray System which produces cross-sectional body images by computer reconstruction of x-ray transmission data taken at different angles and planes. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 23, 2014 Category: Medical Equipment Source Type: alerts
Bayer Corp - Medrad - Class 2 Recall
Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 31, 2014 Category: Medical Equipment Source Type: alerts
GE Healthcare - Centricity PACS Workstation - Class 2 Recall
The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professional, including radiologists, physicians, technologists, clinicians, and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print, and export images when connected wit the Centricity PACS infrastructure. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 29, 2014 Category: Medical Equipment Source Type: alerts
Philips Healthcare Informatics, Inc. - Philips XRE, the dictation editor system included in the Philips XIRIS 8.1.50 - Class 2 Recall
Philips XRE, the dictation editor system included in the Philips XIRIS 8.1.50 XIRIS is a radiology information system (RIS) is a computer system that assist radiology services in the storing, manipulating and retrieving of patient information. This included patient scheduling and tracking and workflow and reporting management. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 22, 2014 Category: Medical Equipment Source Type: alerts
Mckesson Medical Immaging - Picture Archive Communication System (PACS) - Class 2 Recall
McKesson Radiology-PACS. McKesson Radiology is a medical image and information 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 - May 14, 2014 Category: Medical Equipment Source Type: alerts
