Medical equipment, implants, and diagnostic devices
A problem has been detected with the Philips LI-Polymer rechargeable battery when used with its approved charging station and module charger. When the battery is inserted into a charger bay, the LED indicatory lights solid red and the battery will not charge. This may result from poor electrical contact between the battery and charger.
Multiple lots being recalled due to a product design issue
A problem has been detected with the Philips LI-Polymer rechargeable battery when used with its approved charging station and module charger. When the battery is inserted into a charger bay, the LED indicatory lights solid red and the battery will not charge. This may result from poor electrical contact between the battery and charger.
Sterile introducer sheath set manufactured under one lot with different expiration dates.
Suspect poor weld on back KD bar.
Dental implant cap label may incorrectly indicate implant measurements 5.0x8mm. Actual implant measurements are 4.3x10mm. If not noticed prior to implant placement, this could lead to: 1) A second surgical procedure; 2) Implant replacement; 3) If placed in posterior lower jaw, the implant may damage the inferior alveolar nerve canal or perforate a small artery requiring immediate implant removal.
LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim.
LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim.
Smith & Nephew
The products were improperly heat treated.
The firm registered the product as a Class I device, but has since been informed by FDA that the device is not Class I and requires a 510(k) submission.
FDA revocation of the Emergency Use Authorization due to performance issues
A problem has been detected with the Philips LI-Polymer rechargeable battery when used with its approved charging station and module charger. When the battery is inserted into a charger bay, the LED indicatory lights solid red and the battery will not charge. This may result from poor electrical contact between the battery and charger.
FDA revocation of the Emergency Use Authorization due to performance issues
May have one or more dimensional features out of tolerance includes: thread pitch diameter depth, thread minor diameter depth, plate thickness and end length out of tolerance that can potentially result in a reduced locking strength of an LCP screw
The rivets that secure the elastic headband to the face shield have the potential to be mis-assembled. When this condition occurs, it can result in a headband that can become loose from face shield allowing the face shield to shield on the user.
LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim.
A low risk of a false positive result being issued with a laboratory developed test (LDT) that utilizes the LPH533-A NUP98 Distal Probe Green.
ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Modular Junction Box (MJB) cables can melt and affect the bed functionality.
FDA revocation of the Emergency Use Authorization due to performance issues
Olympus Corporation of the Americas
Mislabeled outer carton: packaged with the outer carton label stating the contents were the 70143662 Smart Piston but the inside package contents was the 70142158 Stapes Piston; see image below