LIFEPAK Express Automated External Defibrillator (AED). Labeling on the device states LIFEPAK CR Plus/LIFEPAK EXPRESS De

FDA device recall Z-0150-2009 · posted 2008-10-30 · Terminated

Recall details

Recalling firm

Physio Control, Inc.

Reason for recall

The device may not power on although it indicates it is ready for use and would not be able to provide defibrillation therapy.

Action taken

On 07/24/08, the firm sent an "URGENT MEDICAL DEVICE RECALL" letter with a confirmation sheet via certified return receipt to customers. The letter notified the customer of the recall and the hazard associated with the recall and provided instructions to customers: 1) Immediately verify the AED powers on and voice prompts begin. After verification, press and hold the On/Off button for approximately two seconds to turn the AED off. 2) Keep the AED in use and perform monthly inspections that include the additional AED power on test. Perform a monthly inspection which is consistent with the device labeling. 3) If "OK" is visible on the Readiness Display and AED powers on, it is ready for use. 4) If, at any time, the AED does not power on or if any other indicator displays (i.e. battery or CHARGE-PAK symbol, attention symbol or wrench symbol) immediately call Physio-Control Technical Support (1-800-442-1142). The letter advises customers a Physio-Control representative will contact them within 60 days to arrange a replacement. A confirmation sheet was sent with the letter; to be returned to Physio-Control, Inc. For specific questions or additional information, contact Physio-Control, Inc. at 1-800-442-1142 weekdays between 6:00 a.m. and 4:00 p.m. (PST) or at www.physio-control.com.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

MKJ

Quantity affected

2,230 Units

Distribution

Worldwide including USA (and Puerto Rico) and countries of Argentina, Australia, Bahamas, Barbados, Brazil, Canada , Chile, Colombia, Dominica, Germany, Hong Kong, Hungary, Jamaica, Japan, Mexico, Net

Date initiated

2008-07-24

Date posted

2008-10-30

Date terminated

2013-08-08

Location

Redmond, WA

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