Recall Z-2030-2009 ยท MKJ Automated External Defibrillators (Non-Wearable)
Physio Control, Inc.
Medtronic Physio-Control LIFEPAK CR Plus Defibrillator/Monitor. Automated external defibrillator deployed primarily in public access defibrillator environments where the expected use for any one device is once every 20 months. For use on persons requiring defibrillation therapy.
| Date | Sep 14, 2009 (initiated Jul 31, 2009) |
| Status | Terminated |
| Reason | The K1 relay on the Analog printed circuit board assembly may short due to moisture ingress in a highly humid environment. K1 shorting may affect the ECG amplitude causing the Shock Advisory System(SAS) to not analyze the ECG rhythm correctly thus preventing the device from delivering therapy. |
| Root cause | Nonconforming Material/Component |
| Action | Physio-Control, Inc. notified Customers by phone beginning August 18, 2009. In addition, the recalling firm Issued an "Urgent Medical Device Recall" letter dated August 2009 informing Customers of the affected product and informing them that a Physio-Control representative will call and arrange for immediate device replacement. For further information, contact Physio-Control Customer Care at 1-800-442-1142. |
| Quantity | 34 devices (2 domestically & 32 internationally) |
| Distribution | Worldwide Distribution -- US (DC and MN) and Japan. |
| 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 |