—#194574

Product

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 product code: LWH — Counter, Sponge, Surgical
Device class: Class 1
Medical specialty: General Hospital
510(k) numbers: K060076
Affected lot / code info: UDI-DI (GTIN): 07613327543094; Serial Numbers: GK404E00828 GK404E00933 GK404E00959 GK404E01157 GK405E00282 GK405E00642 GK405E00671 GK405E00675 GK405E00693 GK405E00707 GK405E00757 GK405E00827 GK405E00857 GK405E00914 GK403E00537 GK404E00494 GK405E00176 GK405E00655 GK405E00723 GK403E00031 GK404E00638 GK404E00640 GK404E00700 GK404E00866 GK404E00887 GK404E00945 GK404E01113 GK404E01119 GK404E01121 GK404E01123 GK404E01170 GK404E01171 GK405E00602 GK49CE00058 GK404E00032 GK404E00034 GK404E00043 GK404E00262 GK404E00287 GK404E00287 211071 211115 211265

Why it was recalled

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 (FDA determination)

Under Investigation by firm

Action the firm took

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 Jordan.Greegor@stryker.com. 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.

Recalling firm

Firm: Stryker Instruments Div. of Stryker Corporation
Address: 4100 E Milham Ave, Portage, Michigan 49002-9704

Distribution

Distribution pattern: The products were distributed to the following US states: KS and ME.

Timeline

Recall initiated: 2022-06-15
Terminated: 2024-04-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #194574. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.