Recall Z-2885-2011 ยท MKJ Automated External Defibrillators (Non-Wearable)
Physio Control, Inc.
The LIFEPAK 500 Automated External Defibrillator is a semi-automatic defibrillator that uses a patented Shock Advisory System. This software algorithm analyzes the patient's electrocardiographic (ECG) rhythm and indicates whether or not it detects a shockable rhythm. The LIFEPAK 500 AED requires operator interaction to defibrillate the patient. The LIFEPAK 500 AED is intended for use in the p
| Date | Jul 26, 2011 (initiated Jun 6, 2011) |
| Status | Terminated |
| Reason | The potential reliability issue is the result of a design characteristic of a SRAM (Static Random Access Memory) electronic component on the main printed circuit board assembly. |
| Root cause | Component design/selection |
| Action | Physio-Control, Inc. sent an "URGENT- ACTION REQUIRED" letter dated June 2011 to all affected customers. The letter describes the product, problem, and the action to be taken by the customer. The letter recommends that users who store their device(s) in hard-shelled carrying cases remove them from the case(s)immediately and discontinue the use of the case(s). Additionally, the letter recommends that customers perform regular maintenance in accordance with the Operating Instructions. A Confirmation Sheet was enclosed with the letter for customers to complete and return via fax at 1-866-448- |
| Quantity | 12197 units distributed worldwide (5169 units outside US; 7028 units in the US) |
| Distribution | Worldwide Distribution--USA (nationwide) and the countries of Argentina, Australia, Bahamas, Brazil, Canada, Chile, Columbia, Germany, Hong Kong, Iran, Japan, Mexico, Netherlands, Peru, and Uruguay. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052057 | LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR Medtronic Emergency Response Systems, Inc., Feb 17, 2006 |