The LIFEPAK 500 Automated External Defibrillator is a semi-automatic defibrillator that uses a patented Shock Advisory S
FDA device recall Z-2885-2011 · posted 2011-07-26 · Terminated
Recall details
- Recalling firm
- Physio Control, Inc.
- Reason for recall
- 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.
- Action taken
- 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 1-866-448-9567. Customers can call the Technical Support Team at 1-800-442-1142, Option 5.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 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.
- Date initiated
- 2011-06-06
- Date posted
- 2011-07-26
- Date terminated
- 2012-02-23
- Location
- Redmond, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR (K052057) | Medtronic Emergency Response Systems, Inc. | 2006-02-17 |