Recall Z-0562-05 ยท MKJ Automated External Defibrillators (Non-Wearable)
Medtronic Emergency Response Systems, Inc.
LIFEPAK 500 AED.
| Date | Mar 10, 2005 (initiated Feb 3, 2005) |
| Status | Terminated |
| Reason | Potential to not detect patients at the low end of the patient impedance range. |
| Root cause | Device Design |
| Action | On 2/3/05 the firm issued a 'Medical Device Correction' letter dated January 2005 to their customers. The letter advised customers of the issue and stated a representative from the firm would visit each facility to update affected unit. On 2/25/05 a nationwide press release was issued. On 3/1/05 the firm began telephoning each customer, this was followed by another letter titled MEDICAL DEVICE RECALL. The letter advises of the issue and recommends defibrillators remain in service when no alternative is available until the unit can be corrected. Each unit will be replaced or corrected. On |
| Quantity | 2,349 |
| Distribution | Devices were distributed to 750 domestic consignees dn 16 international consignees. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.