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Recall

Philips issues worldwide recall of 660,000 faulty defibrillators

Three defibrillators manufactured by the company are affected.

THE HEALTH PRODUCTS Regulatory Authority has issued a safety warning after electronics manufacturer Philips recalled 660,000 defibrillators worldwide due to a fault over how the devices alert owners of their self-test results.

The authority has warned Irish healthcare groups, volunteers, caregivers, gyms, schools and sports centres about the fault, which is affecting three types of defibrillator manufactured by Philips Medical Systems.

It says that HeartStart FRx, HeartStart HS1 (Home) and HeartStart HS1 (OnSite) devices manufactured between 2002 and 2013 are affected.

The warning was issued by Philips after it identified a failure in how certain defibrillators alerted users about their routine self-tests via an audible chirp.

The company revealed that it became aware of 13 incidents where the chirp failed during treatment, and delivered at least one shock to the patient being treated before failing.

Among the cases where the patient outcome was known in these instances, 5 patients died and 2 patients were successfully resuscitated and survived.

The HPRA has advised those who may own an affected defibrillator to forward a copy of its safety notice to relevant personnel within their organisations, as well as to any other organisations or people to whom the devices have been transferred.

Any concerns about the devices should also be reported to the authority.

According to the manufacturer, users of any of affected defibrillators which are still under warranty may receive a replacement device from Philips by contacting the company.

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