SurgiCount+ Software Application-indicated as an adjunctive technology for augmenting the manual process of counting, di

FDA device recall Z-2463-2023 · posted 2023-08-25 · Open, Classified

Recall details

Recalling firm

Stryker Corporation

Reason for recall

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

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

PVZ

Quantity affected

57 units

Distribution

US Nationwide distribution.

Date initiated

2023-07-10

Date posted

2023-08-25

Location

Portage, MI