Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1452-2022 — 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.

U.S. FDA — Device Enforcement · United States · 2022-06-15 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1452-2022
Date of alert
2022-06-15
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Stryker Instruments Div. of Stryker Corporation
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
07613327543094
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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