Recall Z-0150-2009 ยท MKJ Automated External Defibrillators (Non-Wearable)
Physio Control, Inc.
LIFEPAK Express Automated External Defibrillator (AED). Labeling on the device states LIFEPAK CR Plus/LIFEPAK EXPRESS Defibrillators with ADAPTIV Biphasic Technology; Medtronic Emergency Response Systems, Inc. 11811 Willows Road NE Redmond, WA. The battery operated, small portable device is primarily deployed in Public Access Defibrillator (PAD) environments where the expected use for any one de
| Date | Oct 30, 2008 (initiated Jul 24, 2008) |
| Status | Terminated |
| Reason | The device may not power on although it indicates it is ready for use and would not be able to provide defibrillation therapy. |
| Root cause | Nonconforming Material/Component |
| Action | 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 |
| Quantity | 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, Netherlands, New Zealand, Singapore, Uruguay, Venezuela, and Virgin Islands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011144 | LIFEPAK 600 AUTOMATED EXTERNAL DEFIBRILLATOR Medtronic Physio-Control Corp., Dec 3, 2001 |