Device product
Stryker USB Converter, Polaris Spectra Camera, Catalog #201148, a component of the Mako Robotic-Arm Assisted Surgery System.
Z-1735-2022
Product summary
- Event
- Event 90727
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2
- Official record key
device-enforcement:Z-1735-2022
Official wording
Reason: Certain units have the potential to exhibit infant failures whereby units either arrive non-functional, have the potential to become non-functional, or flash an error light while in use.
Code information: Lot #22041607, UDI-DI (GTIN) 07613327407280.
Distribution pattern: US Distribution was made to IL and AZ.
Derived failure modes
-
Unknown
Certain units have the potential to exhibit infant failures whereby units either arrive non-functional, have the potential to become non-functional, or flash an error light while in use.