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Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6

FDA Recall #Z-1394-2022 — Class III — December 4, 2018

Recall #Z-1394-2022 Date: December 4, 2018 Classification: Class III Status: Terminated

Product Description

Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6

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.

Recalling Firm

Stryker Instruments Div. of Stryker Corporation — Portage, MI

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Devices

Product Quantity

51 units

Distribution

US Nationwide.

Code Information

UDI-DI (GTIN): 00859506006067; Systems running software versions 4.6.5, 4.8.7, 4.9.6

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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