Recall Z-0343-03 ยท MKJ Automated External Defibrillators (Non-Wearable)
Philips Medical Systems, Inc. Cardiac & Monitoring Systems
Philips HeartStart XL, Model M4735A Defibrillator/Monitor
| Date | Dec 18, 2002 (initiated Nov 25, 2002) |
| Status | Terminated |
| Reason | Defective energy switch may cause Defibrillator to turn off or charge to a different energy level than was selected. |
| Root cause | Other |
| Action | On 11/25/02 Philips notified customers by letter and requested users to identify the device and use an alternate defibrillator. Philips systems representatives will repair the device in the field. Instructions, titled: 'Risk Mitigation Procedure,' were provided if the unit cannot be pulled from service. |
| Quantity | 260 units |
| Distribution | AL, AZ, CA, CT, DE, FL, IL , IN, LA, NE, NY, PA, TX Nationwide Foreign: Canada, Algeria, Belgium, France, Great Britain, Ireland, Israel, Italy, Lebanon, Spain, Sweden, Hong Kong, Philippines, Singapore, Taiwan, China, Japan,Trinadad |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001725 | HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL M4735A Agilent Technologies, Inc., Sep 8, 2000 |
| K010634 | HEARTSTREAM XL DEFIBIBRILLATOR/MONITOR, MODEL M4735A, HEARTSTREAM XLT DEFIBRILLATOR/MONITOR.MODEL M2500B Agilent Technologies, Inc., Jun 11, 2001 |
| K021453 | HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL #M4735A Philips Medical Systems, Jul 3, 2002 |