FDAClass IISeptember 6, 2023

SurgiCount+ Software Application-indicated as an recall: Software Issue

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;

Why was SurgiCount+ Software Application-indicated as an recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

GTIN 07613327543094 Software Version: 2.1.8 & 2.20

Product
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;
Recalling firm
Stryker Corporation
Quantity
57 units
Distribution
US Nationwide distribution.
Recall date
September 6, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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