Device 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;
Z-2463-2023
Product summary
- Event
- Event 92713
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 57 units
- Official record key
device-enforcement:Z-2463-2023
Official wording
Reason: Potential for current software to miscount when scanning in multiple sponge-products from the same unique sponge-pack type
Code information: GTIN 07613327543094 Software Version: 2.1.8 & 2.20
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
Potential for current software to miscount when scanning in multiple sponge-products from the same unique sponge-pack type