Recall Z-1394-2022 ยท FQA Scale, Surgical Sponge
Stryker Instruments Div. of Stryker Corporation
Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6
| Date | Dec 4, 2018 |
| Status | Terminated |
| 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. |
| Root cause | Use error |
| Action | 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. |
| Quantity | 51 units |
| Distribution | US Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.