Recall Z-0963-2026 — The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31 infrared (IR) light-emitting diodes (LEDs) as well as an electronics control unit for the LEDs which includes its own battery power supply. The measured LED positions can be used in on
U.S. FDA — Device Enforcement · United States · 2025-11-12 · Class II
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Reported risk: When the device is activated during surgery, the device software issues an error message "Instrument Face Mask (6001385000000) is not valid for this application" resulting in an inability to use the device.
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