Recall Z-2463-2023— Stryker Corporation
Class II · Ongoing
Class II FDA medical device recall by Stryker Corporation, initiated 2023-07-10. FDA's recall record names no specific 510(k) clearance for this event. 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;. Reason: Potential for current software to miscount when scanning in multiple sponge-products from the same unique sponge-pack type.
- Recalling firm
- Stryker Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-07-10
- Firm location
- Portage, MI, United States
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.