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

Recall Z-1417-2017 — HeartStart MRx Monitor/Defibrillator, Model numbers: M3535A (M3535ATZ) M3536A (M3536ATZ), M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9

U.S. FDA — Device Enforcement · United States · 2017-02-24 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1417-2017
Date of alert
2017-02-24
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Philips North America, LLC
Product category
device
Product type
Devices
Reported risk: HeartStart MRx Monitor/Defibrillator may may exhibit abnormal behavior when operating using a single battery as the sole source of power may fail to deliver therapy or monitoring
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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