The LIFEPAK 500 Automated External Defibrillator is a semi-automatic defibrillator that uses a patented Shock Advisory S
FDA device recall Z-1773-2013 · posted 2013-07-19 · Terminated
Recall details
- Recalling firm
- Physio Control, Inc.
- Reason for recall
- The LIFEPAK 500 Automated External Defibrillator (AED) could be susceptible to malfunction due to an assembly error. If affected, the malfunction would be the result of internal shorting on a printed circuit board assembly and could render the device inoperable.
- Action taken
- The firm, Physio-Control Inc., contacted their consignees by telephone or email starting on June 13, 2013 and sent and/or delivered an "URGENT MEDICAL DEVICE CORRECTION" letter dated June 2013 to its customers. The letter described the product, problem and actions to be taken. A Physio-Control representative will be contacting the customers by direct visit, telephone, or email you to coordinate the replacement of their device(s). Customers with questions regarding this notification, please call Physio's Technical Support at 1-800-442-1142, 6:00 a.m. to 4:00. pm. (Pacific), Monday-Friday.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 139 total (125 units in the US and 14 units outside US)
- Distribution
- Worldwide distribution: US (nationwide) including states of: IL, MA, NC, ND, NY, PA, RI, TX, WA, and WI; and country of: Canada.
- Date initiated
- 2013-06-12
- Date posted
- 2013-07-19
- Date terminated
- 2013-09-19
- 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 |