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Get the Medical Devices newsletterSign up to our free email to get all the latest medical devices news.US-based HeartSine Technologies has initiated a voluntary recall of some older PDU 400 personal defibrillators on 10 October 2013.
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The recall is due to a self-test defect that may affect the ability of the device to deliver therapy to a patient in a sudden cardiac arrest (SCA) event.
Rather than emitting a timely alarm warning that the device has insufficient battery, it can appear to be ready for use, but when called upon to deliver therapy the device may not have sufficient capacity to do so.
These devices were sold between May 2008 and April 2011.
No other PDU 400 devices are affected by the present recall.
The older PDU 400 devices affected by this issue have serial numbers between 08P00001003 and 11P00007347.
HeartSine Technologies is contacting customers with affected devices to arrange a replacement device immediately.