Philips Heartstart MRx Monitor/Defibrillator Models: M3535A (Hospital Use) , M3536A (EMS Use)
FDA device recall Z-0341-05 · posted 2004-12-21 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems
- Reason for recall
- In Software versions below A.02.00, with the sync function enabled and the device switched from manual to AED, there may be an unexpected delay in delivery of energy
- Action taken
- Philips notified customers on 12/13/04 by letter. Users are provided with action required to Mitigate Risk' until the correction is made by a Systems representative.
- Root cause
- Other
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 2520 units
- Distribution
- Nationwide Foreign:Canada, Austria, Australlia, Belgium, China, Denmark, Finland, France, Germany, Israel, Italy,Kuwait, Latvia, Lebannon, Libya, Netherland,Norway, Portugal, Qatar, Russia, Singapore,
- Date initiated
- 2004-12-15
- Date posted
- 2004-12-21
- Date terminated
- 2016-02-02
- 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 |