Health Canada — Medical Devices · Canada · 2023-11-17 · Type II
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Reported risk: Philips has identified a potential safety and compliance issue: the HeartStart Intrepid Monitor/Defibrillator's service manual does not detail electrical safety test verification methods as required by International Electrotechnical Commission(IEC) requirements for class I devices. The current HeartStart Intrepid service manual does not detail IEC class I electrical safety test verification methods. The lack of this testing does not introduce a failure, but it may prevent a failure from being detected. This could occur when an IEC class I device is tested as a class II device after a servicing event. The issue was identified as the result of a service provider's inquiry. There have been no reports of patient harm. Recall start date: October 19, 2023
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