#gray-zone

FDA Recall: Boston Scientific Corporation, System, Image Processing, Radiological

Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calculator to modify one or more input. When a user modifies an input and selects "Recalculate", the dose calculation is updated correctly; however, any vials that…

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.