Recall Z-0940-03 ยท MKJ Automated External Defibrillators (Non-Wearable)
Medtronic Physio Control Corp
LIFEPAK CR Plus defibrillator
| Date | Jun 12, 2003 (initiated May 23, 2003) |
| Status | Terminated |
| Reason | Defibrillation therapy may be delayed or not delivered for persons needing defibrillation therapy. |
| Root cause | Other |
| Action | On 5/23/03, the firm issued a recall letter to customers advising of the malfunctions and instructions to check the device to assure it is ready for use. Service representatives will visit the customer sites and replace the flex circuit in all affected devices. |
| Quantity | 7095 devices |
| Distribution | The firm distributed units worldwide. Foreign distribution includes Australia, Canada, Costa Rica, Hong Kong, India, Israel, Jamaica, Netherlands, New Zealand, Saudi Arabia, South Africa, Uruguay. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011144 | LIFEPAK 600 AUTOMATED EXTERNAL DEFIBRILLATOR Medtronic Physio-Control Corp., Dec 3, 2001 |