Class I - Dangerous
Potential for RadSuite AV viewer to skip image slices when the user presses page up or page down when the viewer displays multiple viewports and the user has mouse focused on any viewport other than the first viewport.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
OEC UroView 2800, fluoroscopic x-ray system
GE OEC Medical Systems
Class I - Dangerous
A firmware issue in the supplied LCD workstation monitor(s). Under some circumstances, the monitor(s) may appear dark with no video displayed.
Conical portio adapter (acorn) small & large are used for examination and diagnosis in conjunction with endoscopic accessories in gynecological laparoscopy, to determine patency of the fallopian tubes.
Richard Wolf Medical Instruments
Class I - Dangerous
The distal end of the Conical portio adapter (acorn) is composed of a small cap (head) that partially sits inside a hollow shaft (tube). These two parts are welded together to create one piece. In the impacted batches of product, the weld was improperly performed. As a result, the two pieces are not properly joined. This potential failure can result in the separation of the two pieces. The possible separation of these two components presents a potential risk to patients.
Panacea Air Pro Mattress Control Unit, Model: Platinum 5000, US Model Number 5000. Use with alternating pressure air flotation mattress.
American National Mfg
Class I - Dangerous
The Panacea Air Pro Mattress Control Unit is being recalled due to a firmware problem, which may result in the device not having the firmness range required.
Class I - Dangerous
The adhesive may be inadequately applied or the assembly may be manipulated after application of the adhesive resulting in an incomplete bond to the angled tip.
The batteries have the potential to overheating, melt or char.
Class I - Dangerous
A version of the dual dispersive electrodes may not be compatible with some electrosurgical generators, placing patients at risk for undetected pad lift and a potential burn.
Class I - Dangerous
A version of the dual dispersive electrodes may not be compatible with some electrosurgical generators, placing patients at risk for undetected pad lift and a potential burn.
Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.
Class I - Dangerous
Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute timer dialogs or beeper will occur until the unit is rebooted.
RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 4R, REF 90-SRK-311400, QTY: 1, STERILE R,
Medtronic Sofamor Danek USA
Class I - Dangerous
The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
A version of the dual dispersive electrodes may not be compatible with some electrosurgical generators, placing patients at risk for undetected pad lift and a potential burn.
The batteries have the potential to overheating, melt or char.
Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) & 3389S-40 (p/n 3389S0008V).
Medtronic Neuromodulation
Class I - Dangerous
Medtronic has voluntarily decided to retrieve unused Model 3387S-40 and 3389S-40 DBS leads from three manufacturing lot numbers. During the manufacturing process of a DBS lead component, Medtronic identified the potential for lead insulation damage.
The batteries have the potential to overheating, melt or char.
Class I - Dangerous
78 Viva CRT -Ds and Evera ICDs that were manufactured with a specific subset of circuit components may experience rapid battery depletion due to a low resistance path developing within the circuit component. There have been seven (7) confirmed failures (9%) through July 16, 2016. Reported complications have included shortness of breath, pocket heating, low heart rate, and early device explant.
TIBIAL TRAY , SIZE 4, REF 90-SRK-200400, QTY: 1, STERILE R, Responsive Orthopedics, total knee replacement
Medtronic Sofamor Danek USA
Class I - Dangerous
The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
Class I - Dangerous
Vision RT Ltd received three (3) reports from different sites that discovered the following issue, unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during patient set-up for the Optical Surface Monitoring System [OSMS]. 1. CRM 3194, No Serious Injury, No MDR, Aware date: Dec 11, 2015 2. CRM 3321, No Patient Involved, No MDR, Aware date: Jan 19, 2016 3. CRM 4570, No Serious Injury, No MDR, Aware date: March 15, 2016 No patient harm was reported in any of these cases.
Due to the potential for pocket adaptor conductor wire fractures involving DBS Pocket Adaptor Model 64001 and Model 64002, a safety notification was sent to healthcare professionals to reinforce device specific labeling for the handling of pocket adaptors and system integrity checking during implant procedures.
The batteries have the potential to overheating, melt or char.