25
Aug
2023

FDA Recall: Software Can Miscount When Scanning Multiple Products

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Company: Stryker Corporation

Date of Enforcement Report: 08/25/2023

Class II

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.

Recall Number:

Z-2463-2023

REASON:

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

RECALLING FIRM/MANUFACTURER:

Stryker Corporation

VOLUME OF PRODUCT IN COMMERCE:

57 units

DISTRIBUTION:

US Nationwide distribution.

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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