Philips Medical Systems (Cleveland) Inc - Philips Healthcare Brilliance 10 Slice - Class 2 Recall
Brilliance 10 Slice (Air), Model 728251 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 - December 1, 2018 Category: Medical Devices Source Type: alerts
Philips Medical Systems (Cleveland) Inc - Vereos PET/CT - Class 2 Recall
Vereos PET/CT, Software version 2.0.1. Model Number: 882446 Product Usage: The Philips Vereos PET/CT system is a diagnostic imaging device that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem images anatomical cross-sections by computer reconstruction of X-ray transmission data. The PET subsystem images the distribution of PET anatomy-specific radiopharmaceuticals in the patient. The PET/CT system is used for the purposes of detecting, localizing, diagnosing, staging, re-staging, and follow-up for monitoring therapy response of various diseases in oncology, cardiol...
Source: Medical Device Recalls - November 1, 2018 Category: Medical Devices Source Type: alerts
Philips Medical Systems (Cleveland) Inc - Philips IQon Spectral CT - Class 2 Recall
Ingenuity CT (Model No. 728326), software version 4.1.6 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. 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 ...
Source: Medical Device Recalls - November 1, 2018 Category: Medical Devices Source Type: alerts
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
Philips Medical Systems (Cleveland) Inc - Philips Brilliance iCT - Class 2 Recall
Brilliance iCT (Model No. 728306), Software Version 4.1.6 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
Philips Medical Systems (Cleveland) Inc - Philips Brilliance Big Bore Oncology - Class 2 Recall
Brilliance Big Bore Oncology CT (Model No. 728243) 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
Philips Medical Systems (Cleveland) Inc - Philips IQon Spectral CT - Class 2 Recall
IQon Spectral CT (Model No. 728332), Software Version 4.7.0 or 4.7.2 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
Philips Medical Systems (Cleveland) Inc - Philips Ingenuity Core - Class 2 Recall
Ingenuity Core (Model No. 728321), Software version 4.1.6 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
Philips Medical Systems (Cleveland) Inc - Philips Brilliance 64 - Class 2 Recall
Brilliance 64 (Model No. 728231), Software version 4.1.6 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
Philips Medical Systems (Cleveland) Inc - Philips Brilliance iCT SP - Class 2 Recall
Brilliance iCT SP (Model No. 728311, Software Version 4.7.0 or 4.7.2 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
Philips Medical Systems (Cleveland) Inc - Philips Ingenuity Core 128 - Class 2 Recall
Ingenuity Core 128 (Model No. 728323), Software version 4.1.6 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
Data Innovations, LLC - IM Abbott Alinity ciseries (abdicqii) accessory driver - Class 2 Recall
IM Abbott Alinity ci-series (abdicqii) accessory driver v8.00.0001 software product that can receive information from a hospital computer system (also called a Laboratory Information System [LIS]). (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 23, 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
Roche Diagnostics Corporation - Roche cobas p 612 preanalytical system - Class 2 Recall
Roche cobas p 612 pre-analytical system (63x) Model: 07563116001 The cobas p 612 pre-analytical system is a computer controlled fully automatic system for sorting of open and closed barcoded and centrifuged and non-centrifuged sample tubes. The cobas p 612 is intended for use with analyzers that perform tests in the area of clinical chemistry, immuno chemistry, coagulation, hematology, urinalysis, nucleic acid testing. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 28, 2018 Category: Medical Devices Source Type: alerts
Think Surgical, Inc. - Think Surgical Cutter - Class 2 Recall
Think Surgical Cutter, Flat, ¿6.2mm x 144mm. For use only with the TCAT Computer-Assisted Tool. Part Number 106428 The cutter is used to prepare the bone for the (TKA) Total Knee Arthroplasty. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 7, 2018 Category: Medical Devices Source Type: alerts
