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

Recall Z-2189-2024 — Infinity Acute Care System (IACS) Monitoring System, Infinity M500 with Power, Model No. MS20407. Rev 20, 21, and 23

U.S. FDA — Device Enforcement · United States · 2024-05-13 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2189-2024
Date of alert
2024-05-13
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Draeger Medical Systems, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
04049098054447
Reported risk: Device is not in full compliance to Type CF requirements of IEC 60601-1 and IEC 60601-2-34 standards. Therefore, there is a potential risk of electric shock. Health consequences may include electrical shock, burns, and cardiac arrhythmia.
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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