Device product
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.
Z-0963-2026
Product summary
- Event
- Event 97988
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 320 units
- Official record key
device-enforcement:Z-0963-2026
Official wording
Reason: 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.
Code information: Part Number: 6000-390-000; UDI-DI: 37613327097628; Lots: 6000106885, 6000106894, 6000106895, 6000106896;
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Germany, Japan, South Korea.
Derived failure modes
-
Device software or design
software issues an error