The FDA has issued a Class I Recall of certain LIFEPAK 20 and LIFEPAK 20e external defirillator/monitors, from Physio-Control, due to a possible failure on the power supply assembly.

The power supply failure can result in either "No DC power" or "No DC or AC power". A failure of DC (battery) power can result in the inability to deliver defibrillation therapy if the device will not turn on using DC (battery) power and no AC (line) power is available.

All affected power supplies will be updated. Customers are advised to keep the defibrillators in service and follow recommended daily operator checklist steps while service updates are scheduled.

Approximately 42,943 devices, distributed worldwide between September 16, 2002 and September 27, 2007, may be affected. Users can search for affected devices by serial number on Physio-Control’s Web site. Adverse events should be reported to the FDA’s MedWatch adverse event reporting program.