Philips HeartStart XL, Defibrillator/Monitor Model number M4735A Product Usage: The M4735A HeartStart XL Defibrillator/M
FDA device recall Z-1109-2014 · posted 2014-02-26 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems, Inc.
- Reason for recall
- Philips HeartStart XL may experience a power board failure causing failure to defibrillate
- Action taken
- Philips Healthcare issued an Urgent Medical Device Correction notification/Field Safety Notice dated February 2014 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were informed Philips Healthcare Representative will perform a hardware upgrade free of charge. Customers were instructed while awaiting the replacement power board for your device, you may continue to use the HeartStart XL. Identify a readily available backup defibrillator to use in the event the affected HeartStart XL fails to deliver therapy. If you need any further information or support concerning this issue, please contact your local Philips representative at 1-800-722-9377
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 5234 units
- Distribution
- Worldwide Distribution and USA Nationwide and the countries of AUSTRALIA, BANGLADESH, BELGIUM, BRAZIL, CANADA, CHINA, COLOMBIA, ETHIOPIA, FINLAND, FRANCE, GEORGIA, GERMANY, HUNGARY, INDIA, INDONESIA,
- Date initiated
- 2014-02-14
- Date posted
- 2014-02-26
- Date terminated
- 2016-06-16
- Location
- Andover, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HEARTSTART MRX WITH Q-CPR OPTION, MODELS M3535A OR M3536A (K051134) | Philips Medical Systems | 2005-09-08 |