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

Recall Z-0862-2019 — LIFEPAK 15 Monitor/Defibrillator Product Usage: The LIFEPAK(R) 15 Monitor/defibrillator (LP15) is a complete acute cardiac care response system designed for basic life support (BLS) and advanced life support (ALS) patient management protocols. The LP15 monitor/defibrillator is intended for use b

U.S. FDA — Device Enforcement · United States · 2019-02-01 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0862-2019
Date of alert: 2019-02-01
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Physio-Control Inc
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 38344771

Reported risk: Certain LIFEPAK 15 Monitors/ Defibrillators were reported to experience a lockup condition after a shock was delivered. This condition is defined as a blank monitor display with LED lights on, indicating power on the device, but no response in keypad and device functions.

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.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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