FDA-Device2023-09-06Class II
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;
Stryker Corporation
Hazard
Potential for current software to miscount when scanning in multiple sponge-products from the same unique sponge-pack type
Sold states
US Nationwide distribution.
Affected count
57 units
Manufactured in
1941 Stryker Way, N/A, Portage, MI, United States
Products
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;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2463-2023Don't want to check this manually?
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