Recalls / —
—#194430
Product
Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6
- FDA product code
- FQA — Scale, Surgical Sponge
- Device class
- Class 1
- Medical specialty
- General Hospital
- Affected lot / code info
- UDI-DI (GTIN): 00859506006067; Systems running software versions 4.6.5, 4.8.7, 4.9.6
Why it was recalled
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 (FDA determination)
Use error
Action the firm took
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.
Recalling firm
- Firm
- Stryker Instruments Div. of Stryker Corporation
- Address
- 4100 E Milham Ave, Portage, Michigan 49002-9704
Distribution
- Distribution pattern
- US Nationwide.
Timeline
- Recall initiated
- 2018-12-04
- Terminated
- 2024-03-11
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #194430. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.