Recall Z-0004-06 ยท MKJ Automated External Defibrillators (Non-Wearable)
Medtronic Emergency Response Systems, Inc.
Hard shell carry case for the LIFEPAK 500 AED.
| Date | Oct 4, 2005 (initiated Jul 12, 2005) |
| Status | Terminated |
| Reason | Some hard shell carry case for LIFEPAK 500 and LIFEPAK CR Plus automated external defibrillators may have blocked pressure vent which may make it difficult to open the case after a sudden decrease in altitude (such as in aircraft landng or mountain descent). |
| Root cause | Process control |
| Action | On 7/12/05 the firm issued a letter to customers instructing the customers to inspect the cases for blocked vent. If the customer noted that the vent was blocked, to contact the firm for a replacement case. The firm provided response cards for the customers to return stating they had inspected their units. |
| Quantity | 4608 cases |
| Distribution | Cases were distributed nationwide and internationally. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010918 | LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM Medtronic Physio-Control Corp., Aug 23, 2001 |