Recall Z-2463-2023 ยท PVZ Non-Stainless Steel Needle
Stryker Corporation
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;
| Date | Aug 25, 2023 (initiated Jul 10, 2023) |
| Status | Open, Classified |
| Reason | Potential for current software to miscount when scanning in multiple sponge-products from the same unique sponge-pack type |
| Root cause | Under Investigation by firm |
| Action | Stryker issued Urgent Medical Device Correction Letter addressed to: IT Director, Materials Manager, Risk Manager, OR Director, OR Coordinator sent July 10, 2023 via 2-day Fed'X delivery. Letter states reason for recall, health risk and action to take: 1. Immediately review this software update notification. Advise OR staff, and all other personnel who may use this product, of the information in the notification. 2. Ensure all Stryker surgical tablets using Surgicount+ software is connected to the local facility Wi-Fi so that the software update can be automatically transmitted. Press INSTALL |
| Quantity | 57 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.