Recall Z-1452-2022 ยท LWH Counter, Sponge, Surgical
Stryker Instruments Div. of Stryker Corporation
SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002-090. Used for counting, displaying, recording and locating the number of RFID-tagged absorbent articles used during surgical procedures.
| Date | Jun 15, 2022 |
| Status | Terminated |
| Reason | When scanning sponges out after a surgical procedure, an error may allow for a duplicate sponge to be counted without the prompt to make a case note and allowing the case to close. The software update will prevent the occurrence of this error. |
| Root cause | Under Investigation by firm |
| Action | Urgent Notification Software Update Notification letters dated June 2022 were sent to customers. Stryker Instruments will be updating the software on all SurgiCount+ Tablets (0794-001-010) distributed on or before May 1, 2022. Actions to be Taken 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. A local Stryker representative will schedule and perform the software update on each SurgiCount+ Tablet. A form, documenting the software update, will be completed by the Stryker Sa |
| Quantity | 44 units |
| Distribution | The products were distributed to the following US states: KS and ME. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060076 | SURGICOUNT SAFETY-SPONGE SYSTEM Surgicount Medical, Mar 14, 2006 |