Medical equipment, implants, and diagnostic devices
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.
PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.
Smith & Nephew
The stem taper on this device is undersized; the gauge point is not deep enough.
Some IntellaMap Orion High Resolution Mapping Catheters are exhibiting a failure mode in which a glue bond on the Deployment Interlock Button has been observed to fail in the field.
Incorrect serial number of tibial inserts packaged in tray may result in inserts not fitting
Biomet Microfixation
Laser etching on the parts is wider and deeper than the conditions previously validated.
PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.
Mevion Medical Systems
Software defect that causes an incorrect dose compensation function to be applied to the internal dose ionization chamber when either pressure or temperature sensor malfunction. This could result in an incorrect dose delivery of no more than 5%.
Instrumed International
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.
Instrumed International
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.
PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.
The product is sold and labeled as EO sterilized, however the units were not sterilized prior to shipment to customers.
In certain operating room environments, a colored screen image occurs with the 1488 Cameras that were manufactured during a specific time period
Biomet Microfixation
Laser etching on the parts is wider and deeper than the conditions previously validated.
Philips Medical Systems
It was discovered the CT portion of the scan was interrupted ( stopping the CT exposure at the time of interruption) and did not complete successfully.
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.
Instrumed International
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.