Health Canada — Medical Devices · Canada · 2019-10-25 · Type II
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Reported risk: Philips has identified that the HeartStart XL+ defibrillator/monitor (model number 861290) may fail to turn on or unexpectedly attempt to restart, rendering it unable to return to a ready for use state. Although the device indicates to the user that it is not ready for use, a failed restart may result in a delay in therapy if the defibrillator/monitor is needed for immediate use. This device behavior may be caused in some cases by a defect in the heartstart's memory management software and in other cases by a malfunction of the system on module (SOM) installed on the processor printed circuit assembly (PCA).
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