Philips Medical Systems (Cleveland) Inc - Brilliance 64 - Class 2 Recall
Brilliance 64, 728231 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. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 14, 2019 Category: Medical Devices Source Type: alerts
Topcon Medical Systems, Inc. - Topcon Ophthalmic Data System - Class 2 Recall
IMAGEnet 6 v1.53- IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and management of digital images, patient data, diagnostic data and clinical information from Topcon devices without controlling or altering the functions and parameters of any medical devices or through computerized networks. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 13, 2019 Category: Medical Devices Source Type: alerts
COMPUTER EYE RELIEF (Conium Maculatum, Natrium Muriaticum, Ruta Graveolens, Senega Officinalis) Solution/ Drops [Similasan Corporation]
Updated Date: Mar 21, 2019 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - March 21, 2019 Category: Drugs & Pharmacology Source Type: alerts
Philips Medical Systems (Cleveland) Inc - Ingenuity TF PET/CT (nonRoHS) - Class 2 Recall
Ingenuity TF PET/CT (non-RoHS), Model Number 882456 This device is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging). (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 13, 2019 Category: Medical Devices Source Type: alerts
NEUSOFT MEDICAL SYSTEMS IMP & EX - NeuViz 128 Multislice CT Scanner System - Class 2 Recall
NeuViz 128 Multi-slice CT Scanner System with software version 1.0.8.5010O+P04 Vi .0.8.521 9+PO1 Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 6, 2019 Category: Medical Devices Source Type: alerts
Edwards Lifesciences, LLC - Swan Ganz Thermodilution Catheter - Class 1 Recall
Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF131F 7J Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly determine hemodynamic pressures and cardiac output when used with a compatible cardiac output computer. Swan-Ganz thermodilution catheters are indicated for the assessment of a patient s hemodynamic condition through direct intra-cardiac and pulmonary artery pressure monitoring, cardiac output determination, and for infusing solutions. The distal (pulmonary artery) port also allows sampling of mixed venous blood for the assessment of oxygen transport b...
Source: Medical Device Recalls - February 1, 2019 Category: Medical Devices Source Type: alerts
Edwards Lifesciences, LLC - Swan Ganz Thermodilution Catheter - Class 1 Recall
Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 151F7 Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly determine hemodynamic pressures and cardiac output when used with a compatible cardiac output computer. Swan-Ganz thermodilution catheters are indicated for the assessment of a patient s hemodynamic condition through direct intra-cardiac and pulmonary artery pressure monitoring, cardiac output determination, and for infusing solutions. The distal (pulmonary artery) port also allows sampling of mixed venous blood for the assessment of oxygen transport ba...
Source: Medical Device Recalls - February 1, 2019 Category: Medical Devices Source Type: alerts
Edwards Lifesciences, LLC - Swan Ganz Thermodilution Catheter - Class 1 Recall
Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131VF7P Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly determine hemodynamic pressures and cardiac output when used with a compatible cardiac output computer. Swan-Ganz thermodilution catheters are indicated for the assessment of a patient s hemodynamic condition through direct intra-cardiac and pulmonary artery pressure monitoring, cardiac output determination, and for infusing solutions. The distal (pulmonary artery) port also allows sampling of mixed venous blood for the assessment of oxygen transport ...
Source: Medical Device Recalls - February 1, 2019 Category: Medical Devices Source Type: alerts
Edwards Lifesciences, LLC - Swan Ganz Thermodilution Catheter - Class 1 Recall
Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131F7P (5 pack of 131F7) Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly determine hemodynamic pressures and cardiac output when used with a compatible cardiac output computer. Swan-Ganz thermodilution catheters are indicated for the assessment of a patient s hemodynamic condition through direct intra-cardiac and pulmonary artery pressure monitoring, cardiac output determination, and for infusing solutions. The distal (pulmonary artery) port also allows sampling of mixed venous blood for the assessment of ...
Source: Medical Device Recalls - February 1, 2019 Category: Medical Devices Source Type: alerts
Riverpoint Medical, LLC - RP RIVERPOINT MEDICAL 18G Brachy Grid B&K(TM) style - Class 3 Recall
RP RIVERPOINT MEDICAL 18G Brachy Grid B&K(TM) style, REF RPG-18 Product Usage: The Riverpoint Brachytherapy Grid is used during Brachytherapy procedures to assist with the precise insertion of the needle or other probes. The Riverpoint Brachytherapy Grid is placed against the skin of the patient to help the user place the needles in a grid pattern. The letters and numbers can also correspond with computerized grids to aid in placement. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 29, 2019 Category: Medical Devices Source Type: alerts
Philips Medical Systems (Cleveland) Inc - Philips Healthcare 16 Slice (Power) - Class 2 Recall
Brilliance 16 Slice (Power), Model 728240 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 - Philips Healthcare Brilliance 64 - Class 2 Recall
Brilliance 64, Model 728231 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 - Philips Healthcare Brilliance 40 - Class 2 Recall
Brilliance 40, Model 728235 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 - Philips Healthcare Brilliance 16 Slice - Class 2 Recall
Brilliance 16 Slice (Air), Model 728246 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 - Philips Healthcare Brilliance 6 Slice - Class 2 Recall
Brilliance 6 Slice (Air), Model 728256 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
