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FDA designates recall of external defibrillator as Class 1

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The FDA has designated Philips Healthcare’s product recall of an external monitor and defibrillator as a Class 1 recall, the most serious kind. The recall affects 47,362 devices manufactured and distributed between 2004 and 2016.

Battery and electrical connection issues in the device (HeartStart MRx Monitor/Defibrillator), used to pace patients with bradycardia or shock patients with sudden cardiac arrest, may prohibit it from charging, powering up and delivering electrical shock therapy, according to a MedWatch report from the FDA.

The agency wrote that the device may also stop pacing, and its use may result in serious injuries such as permanent organ damage and brain injury or death.

Philips Healthcare distributed a notice to customers in February 2017, alerting them to check the device’s model number, inspect the battery connector pins and contact the company for further information and support.