Recall Z-1226-03 ยท MKJ Automated External Defibrillators (Non-Wearable)
Philips Medical Systems
Model M4735A HeartStart XL Defibrillator//Monitor
| Date | Sep 11, 2003 (initiated Sep 2, 2003) |
| Status | Terminated |
| Reason | Instructions For Use include addtional information on configuration for selecting Power on Lead |
| Root cause | Other |
| Action | Philips Medical in conjunction with NNC (National Notification Center) notified users by letter on 9/2/03. Users are provided with Addendum to the HeartStart XL Instructions for Use (to be added to the Instruction for Use) and to familiarize with the configurable Power on Lead. Users are rquested to acknowledge receipt by returning the Business reply Card. |
| Quantity | 16,736 units |
| Distribution | NATIONWIDE Foreign: Canada, Argentina, Brazil, Chile, Costa Rica, Mexico, Paraguay, Peru, Venezuela, Austalia, China,Hong Kong, India, Japan, Malaysia, Manilla, New Zealand, Manila, Singapore,Taiwan,Thailand, Vietnam, ALgeria, Australia,France,Italy, Netherlands,Norway,Oman,Poland, Portugal,South A |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021453 | HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL #M4735A Philips Medical Systems, Jul 3, 2002 |