FDA-Device2025-12-31Class IIPROCESSING DEFECT
Stryker CranialMask Tracker surgical device recalled for software error during surgery
What this means
The Stryker CranialMask Tracker, a surgical tracking device used during head and neck procedures, can display a software error message when activated in the operating room, making it unusable. This affects 320 units worldwide across specific lot numbers. No injuries have been reported.
- Check if your facility has a CranialMask Tracker with part number 6000-390-000 and one of these lot numbers: 6000106885, 6000106894, 6000106895, or 6000106896
- Do not use affected devices during surgery
- Contact Stryker for a replacement or further instructions
- Review your surgical procedures to ensure continuity of patient care
The agency's original wording
Hazard
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide distribution - US Nationwide and the countries of Canada, Germany, Japan, South Korea.
Affected count
320 units
Manufactured in
325 Corporate Dr, N/A, Mahwah, NJ, United States
Products
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 one of three different modes of operation: Patient tracking, Registration using surface matching, and Automatic intra-operative mask registration.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0963-2026Want us to check the next one for you?
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