HeartSine Technologies, Ltd. Recall of some PDU400 Defibrillators

HeartSine Technologies, Ltd.
203 Airport Road West
Belfast, United Kingdom BT3 9ED

On October 10, 2013, HeartSine Technologies, Ltd. initiated a voluntary recall of some older PDU 400 personal defibrillators. 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.

The older PDU 400 devices affected by this issue have serial numbers between:

08P00001003 to 11P00007347

These devices were sold between May 2008 and April 2011. No other PDU 400 devices are affected by the present recall.

HeartSine is contacting customers with affected devices to arrange a replacement device immediately.

Customers with PDU 400 devices with serial number falling within the sequence listed above are asked to contact HeartSine Technologies Ltd. by telephone 00800 12125555 or by email on recallpdu@heartsine.com to organize replacement of the affected devices.