Recall Z-0848-05 ยท MKJ Automated External Defibrillators (Non-Wearable)
Philips Medical Systems
Philips Medical HeartStart MRx Monitor/Defibrillator Model: M3535A, M3536A
| Date | May 17, 2005 (initiated Apr 29, 2005) |
| Status | Terminated |
| Reason | The device may disarm and not deliver shock when performing a Synchronized Cardioversion |
| Root cause | Software design |
| Action | Philips Medical Systems notified accounts by letter on 5/2/05. The firm provided instructions for identifying the effected devices and actions to be taken until the software is availablel for installation. |
| Quantity | 5125 units |
| Distribution | Nationwide Foreign: Canada, Austria, Australia Bahrain, Belgium, Brazil, China, Hong Kong, India, Finland,France, Germany, Hungry, Israel, Italy, Korea, Kuwait, Latvia, Lebanon, Mexico, Namibia, Libya, Netherland, New Zealnd, Norway, Oma, Philippines, Portugal, Qatat, Russia, South Africa, Singapo |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031187 | HEARTSTART MRX, MODEL M3535A Philips Medical Systems, Aug 27, 2003 |