The Medicines and Healthcare products Regulatory Agency, United Kingdom posted a field safety notice concerning all HeartStart MRx monitor/defibrillators (model M3536A) with software versions R.01.00, R.02.00 or R.03.01.
According to the manufacturer, Philips Healthcare, the affected devices may experience unexpected power cycling (system reboot) during device power on (startup). Some devices have been observed to experience rebooting cycles for up to five minutes before the MRx stabilizes. There is a potential that therapy may be delayed.
According to the local supplier, the affected devices had been distributed in Hong Kong and a software update will be provided to address the issue. If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted 03 May 2012