All Recalls

Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.

Failed Impurities/Degradation Specifications

Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.

Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.

Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.

Presence of Foreign Substance: Product complaint for the presence of foreign matter identified as silicone within the tablet.

The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery.

The AutoSPECT Pro application was only designed to reconstruct cardiac SPECT data obtained with detectors positioned at 90¿ or 180¿ relative to one another. However, certain gamma cameras allow for other relative detector angles. Data acquired at these other angles will not be correctly reconstructed by AutoSPECT Pro and the results will likely be erroneous.

The incorrect DFU was packaged with two lots of GDC 360 degree Detachable Coils.

Boston Scientific is recalling all models of Fetch 2 Aspiration Catheter as a result of receiving reports from the field of catheter shaft breaks; including cases requiring the use of a snare or other intervention to retrieve the http://webapps.cdrh.fda.gov/division-tracking/images/trash.pngbroken shaft from the patient.

An electronic component of the Leica M525 OH4 and Leica M720 OH5 surgical microscopes with 400W illumination could potentially overheat, resulting in smoke and smell emanating from the ventilation openings of the illumination units located opposite and away from the surgeon / patient side of the surgical microscope.

There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest.

The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery.

Software bugs in these SOMATOM systems could possibly cause scan aborts, re-scans of patients with additional dose, delayed diagnosis and as worst case scenarios, could possibly cause the need of additional contrast medium, accidental x-radiation to the user or impede customer workflow.

There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest.

Reports of an abnormally high frequency of squelch events on Xhibit Telemetry Receivers (XTR), which is indicative of the loss of the telemetry data signal. In some cases, the Xhibit Central Monitor was also reported to display an Xhibit Offline error message for all patients being monitored.

The incorrect DFU was packaged with two lots of GDC 360 degree Detachable Coils.

The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery.

The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery.

The AutoSPECT Pro application was only designed to reconstruct cardiac SPECT data obtained with detectors positioned at 90¿ or 180¿ relative to one another. However, certain gamma cameras allow for other relative detector angles. Data acquired at these other angles will not be correctly reconstructed by AutoSPECT Pro and the results will likely be erroneous.