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SurgiCount+ Software Application-indicated as an adjunctive technology for augmenting the manual ...

FDA Recall #Z-2463-2023 — Class II — July 10, 2023

Recall #Z-2463-2023 Date: July 10, 2023 Classification: Class II Status: Ongoing

Product Description

SurgiCount+ Software Application-indicated as an adjunctive technology for augmenting the manual process of counting, displaying and recording the number of RFID-tagged absorbent articles used during surgical procedures Product Code: 0694-002-090;

Reason for Recall

Potential for current software to miscount when scanning in multiple sponge-products from the same unique sponge-pack type

Recalling Firm

Stryker Corporation — Portage, MI

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

57 units

Distribution

US Nationwide distribution.

Code Information

GTIN 07613327543094 Software Version: 2.1.8 & 2.20

Status

Ongoing

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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