Z-2463-2023 Class II Ongoing
FDA device recall Z-2463-2023 was initiated by Stryker Corporation on July 10, 2023 and is designated Class II. Reason for recall: Potential for current software to miscount when scanning in multiple sponge-products from the same unique sponge-pack type The recall status is ongoing. Affected quantity: 57 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 6, 2023
- Initiation Date
- July 10, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 57 units
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
Distribution Pattern
US Nationwide distribution.
Code Information
GTIN 07613327543094 Software Version: 2.1.8 & 2.20