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

Recall Z-2393-2020 — DDU-2400EN Lifeline PRO, UDI 00815098020270 - Product Usage: Automated External Defibrillators (AED) are indicated for use on victims of sudden cardiac arrest (SCA) who are: - unconscious and unresponsive, not breathing or not breathing normally.

U.S. FDA — Device Enforcement · United States · 2020-04-27 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2393-2020
Date of alert
2020-04-27
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Defibtech, LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
400101322
Reported risk: A component issue may cause the AED to abort a shock delivery or reset unexpectedly, which may cause an affected device to fail to delivery shock, and/or to fail to deliver shock in range.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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