Recall Z-1773-2013 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 is intended for use by personnel who are authorized by a physician/medical director and is intended for use in
| Date | Jul 19, 2013 (initiated Jun 12, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Employee error |
| Action | 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. |
| Quantity | 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. |
| 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 |