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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker SurgiCount Software Application

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 Class 2 Device Recall Stryker SurgiCount Software Applicationsee related information
Date Initiated by FirmJuly 10, 2023
Date PostedAugust 25, 2023
Recall Status1 Open3, Classified
Recall NumberZ-2463-2023
Recall Event ID 92713
Product Classification Non-stainless steel needle - Product Code PVZ
ProductSurgiCount+ 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;
Code Information GTIN 07613327543094 Software Version: 2.1.8 & 2.20
Recalling Firm/
Manufacturer		 Stryker Corporation
1941 Stryker Way
Portage MI 49002-9711
For Additional Information ContactSAME
269-800-1941
Manufacturer Reason
for Recall		Potential for current software to miscount when scanning in multiple sponge-products from the same unique sponge-pack type
FDA Determined
Cause 2		Under Investigation by firm
ActionStryker 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.
Quantity in Commerce57 units
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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