Device product
Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6
Z-1394-2022
Product summary
- Event
- Event 90448
- Status
- Terminated
- Classification
- Class III
- Quantity
- 51 units
- Official record key
device-enforcement:Z-1394-2022
Official wording
Reason: Gauss Surgical is updating the Instructions for Use (IFU) for our Triton Sponge System in order to clarify proper technique for handling sponges and the calibration placard.
Code information: UDI-DI (GTIN): 00859506006067; Systems running software versions 4.6.5, 4.8.7, 4.9.6
Distribution pattern: US Nationwide.
Derived failure modes
-
Unknown
Gauss Surgical is updating the Instructions for Use (IFU) for our Triton Sponge System in order to clarify proper technique for handling sponges and the calibration placard.