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;
Reported: September 6, 2023 Initiated: July 10, 2023 #Z-2463-2023
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
Details
- Recalling Firm
- Stryker Corporation
- Units Affected
- 57 units
- Distribution
- US Nationwide distribution.
- Location
- Portage, MI
Frequently Asked Questions
What product was recalled? ▼
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;. Recalled by Stryker Corporation. Units affected: 57 units.
Why was this product recalled? ▼
Potential for current software to miscount when scanning in multiple sponge-products from the same unique sponge-pack type
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 6, 2023. Severity: Moderate. Recall number: Z-2463-2023.
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