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

Recall Z-1854-2021 — v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris" System Display, Model H700124, The WorkMate Claris" System is a computer-based electrocardiographic recording and monitoring system designed for efficient capture, display, and retrieval of surface and intracardiac signals during ca

U.S. FDA — Device Enforcement · United States · 2021-05-05 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1854-2021
Date of alert
2021-05-05
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Abbott Laboratories Inc. (St Jude Medical)
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
14774202
Reported risk: Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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