Class I Recall for Physio-Control LIFEPAK 15 Monitor/Defibrillators

Medtronic. Inc’s Physio-Control unit has issued a recall for <"">LIFEPAK 15 monitor/defibrillators manufactured prior to December 16, 2009. The Food & Drug Administration (FDA) has deemed this action a Class I recall, its most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of a device will cause serious adverse health consequences or death.

The LIFEPAK 15 monitor/defibrillator is designed for use by trained medical personnel in out-of-doors and indoor emergency care settings to monitor patient heart rhythms and to treat patients experiencing cardiac arrest. The devices affected by this action were manufactured between March 26, 2009 and December 15, 2009 and distributed between March 27, 2009 and December 15, 2009.

According to the recall notice, an analysis conducted by Physio-Control verified the affected devices were manufactured with an internal component that could cause an electrical short that leads to the device turning off/on by itself or a power loss. A loss of power could delay or prevent delivery of defibrillation therapy. There have been no adverse patient events related to this potential issue.

On March 4, 2010, Physio-Control notified all affected customers by Certified Mail and has begun servicing affected devices, free of charge, at the customer site in most geographies.

Customers are advised to keep units in service and to continue testing their devices in accordance with the Operating Instructions (Section 9–Maintaining the Equipment). Physio-Control service representatives are scheduling service visits to update all affected devices. If your monitor/defibrillator exhibits any power on or power off issues, in the U.S. immediately call our Technical Support at 1.800.442.1142 — option 5, 6:00 A.M. to 4:00 P.M. (Pacific), Monday — Friday. For customers outside the U.S., please contact your local Medtronic Physio-Control representative.

Physio-Control also recommends customers ensure this notification is forwarded to all of their sites. If customers no longer have a LIFEPAK 15 monitor/defibrillator, they are instructed to call Physio-Control as soon as possible.

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