Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6
This recall has been terminated (originally issued December 4, 2018).
- Recall Initiated
- December 4, 2018
- Terminated
- March 11, 2024
- Recall Number
- Z-1394-2022
- Quantity
- 51 units
- Firm Location
- Portage, MI
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
US Nationwide.
Lot / Code Info
UDI-DI (GTIN): 00859506006067; Systems running software versions 4.6.5, 4.8.7, 4.9.6
Root Cause
Use error
Action Taken
Gauss notified customers with a notification letter dated Dec 4, 2018. The letter informed customers that the IFU would be updated in order to clarify proper technique for handling sponges and the calibration placard. No action was required by the customer as the IFU updates were automatically accessible to the user through the iPad application and automatically moved to the newest revision.