Physio-Control handed class I notice for defib recall
This article was originally published in Clinica
The US FDA has classified Physio-Control’s recall of nearly 43,000 units of its LIFEPAK 20 and 20e external defibrillators and monitors as a class I notification, the most severe recall classification. The recall, which was initiated on 27 May, was caused by a possible battery malfunction on defibrillators manufactured prior between 31 July 2002 and 19 September 2007 and have been distributed worldwide. Minneapolis, Minnesota-based Physio-Control, a Medtronic subsidiary, said that the malfunction could delay the delivery of therapy and may potentially cause injury of death. The company said that there was one unconfirmed adverse patient event connected to the LIFEPAK products, over the eight-year product life. Physio-Control said it is currently notifying all its customers both in and outside the US and it plans to update all affected power supplies at no charge, during one field service update at the customer site.