Philips—Model M3536A HeartStart MRx Monitor/Defibrillators: May Not Analyze 12-Lead Electrocardiogram during Acquisition

June 27, 2012 | Risk Management News


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In a June 2012 Urgent Voluntary Medical Device Correction letter submitted by the manufacturer, Philips states that the monitor/defibrillators below may be unable to analyze a 12-lead electrocardiogram (ECG) acquisition, potentially preventing a user from viewing, printing, or transmitting an ECG. Philips also states that the message "Cannot Analyze ECG" will display when the user attempts to collect a report. Because of this problem, users may be unable to acquire a...

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