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

Recall Z-1438-2014 — Philips HeartStart XL+ Defibrillator/Monitor with system software version B.00.00 or B.00.01 installed Model: 861290, automatic external defibrillator.

U.S. FDA — Device Enforcement · United States · 2014-04-02 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1438-2014
Date of alert
2014-04-02
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Philips Medical Systems, Inc.
Product category
device
Product type
Devices
Reported risk: Software communication failure may occur on the HeartStart XL+ locking the user out of clinical mode and possibly causing a delay in therapy.
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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