—#202231

Product

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;

FDA product code: PVZ — Non-Stainless Steel Needle
Device class: Class 2
Medical specialty: General Hospital
Affected lot / code info: GTIN 07613327543094 Software Version: 2.1.8 & 2.20

Why it was recalled

Potential for current software to miscount when scanning in multiple sponge-products from the same unique sponge-pack type

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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 once the update notification appears on the tablet to complete the update. Contact your local sales representative or technical support at 1-800-253-3210 for any assistance or questions. 3. Sign and return the enclosed Business Reply Form to Instruments.recalls@stryker.com. 4. Maintain awareness of this communication internally and inform Stryker if any of the subject devices have been distributed to other organizations. If so, provide contact details so Stryker can inform the recipients accordingly. 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. Please contact Jordan Anderson at (269) 800-1347 or Instruments.recalls@stryker.com with questions or concerns.

Recalling firm

Firm: Stryker Corporation
Address: 1941 Stryker Way, Portage, Michigan 49002-9711

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2023-07-10
Posted by FDA: 2023-08-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #202231. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.