Philips HeartStart XL, Model M4735A Defibrillator/Monitor
FDA device recall Z-0343-03 · posted 2002-12-18 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems, Inc. Cardiac & Monitoring Systems
- Reason for recall
- Defective energy switch may cause Defibrillator to turn off or charge to a different energy level than was selected.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 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, Singapo
- Date initiated
- 2002-11-25
- Date posted
- 2002-12-18
- Date terminated
- 2012-05-03
- Location
- Andover, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL #M4735A (K021453) | Philips Medical Systems | 2002-07-03 |
| HEARTSTREAM XL DEFIBIBRILLATOR/MONITOR, MODEL M4735A, HEARTSTREAM XLT DEFIBRILLATOR/MONITOR.MODEL M2500B (K010634) | Agilent Technologies, Inc. | 2001-06-11 |
| HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL M4735A (K001725) | Agilent Technologies, Inc. | 2000-09-08 |