Cook Inc. - Aprima Access Nonvascular Introducer Set - Class 2 Recall
Aprima" Access Nonvascular Introducer Set Accessories, Catheter Intended for single-puncture percutaneous access to facilitate placement of an .038 inch (0.97 mm) diameter working wire guide for interventional radiology procedures (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 23, 2016 Category: Medical Equipment Source Type: alerts
Cook Inc. - Neff DAgostino Percutaneous Access Set - Class 2 Recall
Neff DAgostino Percutaneous Access Set Accessories, Catheter Intended for single-puncture percutaneous access to facilitate placement of an .038 inch (0.97 mm) diameter working wire guide for interventional radiology procedures (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 23, 2016 Category: Medical Equipment Source Type: alerts
GE Healthcare It - GE Centricity PACS Workstation - Class 2 Recall
GE Centricity PACS Workstation, versions 3.1.1.x through 3.2.1.x Picture Archiving and Communication System Used as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. Also used 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 with the Centricity PACS infrastructure. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 18, 2016 Category: Medical Equipment Source Type: alerts
Philips Medical Systems (Cleveland) Inc - Brilliance BigBore Radiology Computed Tomography Xray systems - Class 2 Recall
Brilliance BigBore Radiology 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. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 10, 2016 Category: Medical Equipment Source Type: alerts
Varian Medical Systems, Inc. - Optical Surface Monitoring System - Class 2 Recall
Optical Surface Monitoring System{OSMS, Varian Private Label} This is used on Varian's TrueBeam EDGE; Radiology: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to Withhold the beam automatically during radiation delivery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 12, 2016 Category: Medical Equipment Source Type: alerts
Varian Medical Systems, Inc. - AlignRT Plus - Class 2 Recall
Optical Surface Monitoring System{Align RT Plus} This is used on Varian's TrueBeam EDGE; Radiology: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to Withhold the beam automatically during radiation delivery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 12, 2016 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA, Inc - SYNGO Breast Care - Class 2 Recall
SYNGO Breast Care, visualization and image enhancement tools to aid radiologist in the review of digital Mammography images and tomosynthesis datasets. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 1, 2016 Category: Medical Equipment Source Type: alerts
Philips Medical Systems (Cleveland) Inc - Big Bore Radiology - Class 2 Recall
Big Bore Radiology tomography X-ray system scanner, model number 728244. The Big Bore Radiology scanner is a whole body computed tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 1, 2016 Category: Medical Equipment Source Type: alerts
Medtronic Navigation, Inc. - Visualase Cooled Laser Applicator System (VCLAS) - Class 2 Recall
Visualase Cooled Laser Applicator System (VCLAS). The VCLAS system consists of the Visualase Laser Diffusing Fiber (LDF) and the Visualase Cooled Catheter System (CCS). The LDF and disposables (including the CCS) is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels of the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, pulmonology, radiology and urology. (Sou...
Source: Medical Device Recalls - May 17, 2016 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA, Inc. - ACUSON X700 Ultrasound System - Class 2 Recall
ACUSON X700 Ultrasound System with software version 1.0.04. Model numbers: 10658844 ACUSON X700 Ultrasound System 10658846 - ACUSON X700 Ultrasound System (Russia) 10658845 - ACUSON X700 Ultrasound System (Korea) Radiology: The Siemens ACUSON X700 ultrasound imaging system is intended for the following applications: Cardiac (Adult, Pediatric), Transesphageal (Cardiac), Intracardiac, Cerebrovascular, Peripheral Vessel, Abdominal, Renal, Fetal, Abdominal, Intra-operative, Pediatric, Small Organ, Neonatal Cepahalic, Adult Cephalic, Orthopedics, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Pelvic, Obst...
Source: Medical Device Recalls - April 28, 2016 Category: Medical Equipment Source Type: alerts
Mckesson Medical Immaging - Horizon Medical Imaging - Class 2 Recall
McKesson Horizon Medical Imaging (HMI) products versions 4.6.1 to including 11.9 and McKesson Radiology (MR) products 12.0 and 12.1.1. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 18, 2016 Category: Medical Equipment Source Type: alerts
Regulatory Insight, Inc - GE Precision MPi - Class 2 Recall
GE Precision MPi is an all-digital multipurpose tilt-C x-ray system, intended for a multitude of diagnostic procedures, including radiology, fluoroscopy, interventional procedures, vascular and non-vascular procedures, and specialized applications including angiographic studies. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 25, 2016 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA, Inc - Syngo.plaza - Class 2 Recall
Syngo Plaza Picture archiving and communication system. Software only. PACS intended to display, process, read, report, communicate, distribute, store and archive digital medical images. Stores and archives within DICOM structured reports. Integrates hospital/radiology information systems. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 24, 2016 Category: Medical Equipment Source Type: alerts
Del Medical, Inc. - Del Medical VS200 radiographic Cassette Holder or Wall Stand - Class 2 Recall
VS200 radiographic Cassette Holder or Wall Stand. For use in radiology department. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 6, 2016 Category: Medical Equipment Source Type: alerts
Del Medical, Inc. - Del Medical VS300 radiographic Cassette Holder or Wall Stand - Class 2 Recall
VS300 radiographic Cassette Holder or Wall Stand. For use in radiology department. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 6, 2016 Category: Medical Equipment Source Type: alerts
