Medical equipment, implants, and diagnostic devices
GE has become aware of multiple issues affecting the Dash 3000/4000/5000 and DashPort 2 monitor. This report of correction encompasses the DashPort 2 device, in which the DashPort 2 stops communicating with the Dash, resulting in Loss of Monitoring at the CIC. The DashPort 2 status LEDs in the back of the unit indicate Unity Network and DashPort 2 to Dash communication has stopped.
Quidel Corporation has initiated a voluntary recall of specific lots of the Sofia Influenza A+B FIA kits because of false positive results which may lead to misdiagnosis.
The firm is recalling the products due to a potential for false negative test results.
Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead wire was removed.
The firm is recalling the products due to a potential for false negative test results.
Lockheed Martin Gyrocam Systems
These camera systems were manufactured by LMGS and found to fail to comply with the FDA laser performance standard during an FDA inspection. These camera systems incorporate Class IIIb surveying, leveling, and alignment lasers and were entered into US commerce without a variance. Additionally, the manufacturer did not submit a product report to FDA for the camera system.
Possible instability of Orthopedic Table Top. If the epoxy bond fails, the aluminum plug may migrate out of the carbon fiber tube. If this occurs, the Orthopedic Table Spar may need to be replaced to ensure stability of the Orthopedic Table Top.
Expired product was shipped to two customers.
Ultradent Products
Incorrect packaging of regular set and fast set cartridges.
The recall was initiated because Breg has determined that some Sterile Polar Pads products manufactured from January 2010 to October 2012 may have sustained damage to the product packaging which may compromise product sterility assurance.
Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead wire was removed.
The firm is recalling the product because the cartridges may contain discs that have an insufficient dose of antibiotic.
Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead wire was removed.
GE Healthcare
GE has become aware of multiple issues affecting the Dash 3000/4000/5000 Patient Monitor. These issues may occur when the Ethernet controller in the XPC823 CPU on the Dash and DashPort 2 motherboard functions intermittently. GE Healthcare has identified that these issues occur most often at sites with large Unity Network installations. It should be noted that the Dash 3000/4000/5000 patient m
Fresenius Medical Care Holdings
There is a small risk of a leak in Cycler Sets and if the Cycler Set is punctured, the dialysate may become contaminated potentially resulting in peritonitis.
Terumo Cardiovascular Systems
Inaccurate readings. Software contains unused (turned off) accuracy correction factors for slope (gain) and offset (bias) for Hematocrit/Saturation calculations. The accuracy on any cuvette size did not meet the specifications.
Viterion telehealth monitors do not transmit "HI" (above the meter's measurable range) and "LO" (below the meter's measurable range) blood glucose readings from Bayer's Contour Elite XL blood glucose meters, or from Roche's Accu-Chek Advantage 03 and 04 meters to healthcare professionals.
The wheelchairs may not meet the specifications of WC-19 (crash testing), therefore the WC-19 verbiage and corresponding logo are removed from the flyers on the Gunnell Rehab Series of Wheelchairs (GRSW).
Viterion telehealth monitors do not transmit "HI" (above the meter's measurable range) and "LO" (below the meter's measurable range) blood glucose readings from Bayer's Contour Elite XL blood glucose meters, or from Roche's Accu-Chek Advantage 03 and 04 meters to healthcare professionals.
Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.