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.
FDA Recall Z-1452-2022 · Posted None
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Recalling FirmStryker Instruments Div. of Stryker Corporation
Recall StatusTerminated
Product CodeLWH
Date Initiated2022-06-15
Date Terminated2024-04-05
Product Quantity44 units
Reason for Recall
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.
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 Sales Representative, and a copy will be provided to your facility.
3. Please complete the enclosed Business Reply Form to confirm receipt of this notification. Return to [email protected].
We apologize for any inconvenience this action may cause your facility. Please forward a copy of this letter to any other personnel within your facility that you deem appropriate.
Root Cause
Under Investigation by firm
Distribution Pattern
The products were distributed to the following US states: KS and ME.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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