Recall Z-0886-04 ยท MKJ Automated External Defibrillators (Non-Wearable)
Medtronic Physio Control Corp
LIFEPAK 500 automated external defibrillator
| Date | Jul 20, 2004 (initiated Apr 2, 2004) |
| Status | Terminated |
| Reason | Potential for batteries to malfunction due to battery cell rupture. |
| Root cause | Other |
| Action | On 4/2/04 the firm initiated telephone contacts to customers to determine if the customer potentially has suspect battery. If so, the customer will be faxed a letter describing how to remove the battery to check for the code date. If customer confirms they have suspect battery, a new battery will be shipped to customer. |
| Quantity | 7028 |
| Distribution | The firm distributed devices nationwide to various hospitals, medical centers, and businesses. The firm also distributed to foreign customers in Australia, Argentina, Brazil, Canada, China, Greece, Hong Kong, Israel, India, Jordan, Mexico, Netherlands, New Zealand, Oman, Philippines, Saudi Arabia, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012428 | MODIFICATION TO: LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR Medtronic Physio-Control Corp., Sep 28, 2001 |