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

Philips HeartStart MRx M3536A Defibrillator/Monitor with Software… — recall Z-1986-2012

U.S. FDA — Device Enforcement · United States · 2012-06-20 · Class II

As described by U.S. FDA — Device Enforcement: Philips HeartStart MRx M3536A Defibrillator/Monitor with Software R.03.03 The Heartstart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by trainin

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1986-2012
Date of alert
2012-06-20
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Philips Healthcare Inc.
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Worldwide Distribution - USA including FL, IN, MA, M, NY, OH, TN, TX, and VA. Internationally to AUSTRALIA, HONG KONG, and INDIA
Reported risk: Defibrillator/monitor cannot analyze an ECG report during acquisition of 12 lead ECG
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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