#gray-zone

FDA Recall: IPG Medical Corporation, Powered Laser Surgical Instrument

Software anomaly that causes a false display of error code 5018.

FDA Recall: Unknown manufacturer, Full-Montage Standard Electroencephalograph

Natus has become aware of two complaints related to the SD LTM 64 PLUS where the EEG traces acquired from two or four different amplifiers used in a multiple amplifier configuration (128 or 256 channels) running firmware version 2022.02 were displayed with a shift of 1 second…

FDA Recall: Medtronic Navigation, Inc.-Boxborough, Interventional Fluoroscopic X-Ray System

Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.