Philips Medical HeartStart MRx Monitor/Defibrillator Model: M3535A, M3536A
FDA device recall Z-0848-05 · posted 2005-05-17 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems
- Reason for recall
- The device may disarm and not deliver shock when performing a Synchronized Cardioversion
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 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
- Date initiated
- 2005-04-29
- Date posted
- 2005-05-17
- Date terminated
- 2010-09-14
- Location
- Andover, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HEARTSTART MRX, MODEL M3535A (K031187) | Philips Medical Systems | 2003-08-27 |