The MHRA is alerting dentists following a notification from Philips that the HeartStart XL+ Defibrillator/Monitor (Model number 861290) may fail to turn on or unexpectedly attempt to restart, and this failed restart may result in a delay if the defibrillator/monitor is needed for immediate use.
Action required
The device is safe to use and can remain in service if it does not exhibit any of the behaviours described above. If it does reboot itself, or fails to start, remove the device from service and contact Philips. Philips will perform a system software upgrade and replace the Processor PCA that contains the SOM module that is subject to failure.
Until the required parts are available and this service is performed, the device should remain removed from service, regardless of whether it is subsequently restarted successfully. For information or support, contact your local Philips representative or the UK Philips Customer Care Service Centre on 0870 532 9741.
