Philips HeartStart FRx Defibrillator, Automated External Defibrillator (AED), catalog number 861304.
FDA device recall Z-0432-2011 · posted 2010-11-22 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems
- Reason for recall
- The affected device may not deliver appropriate defibrillation therapy.
- Action taken
- Philips notified the customer with the affected device by phone on August 8, 2008 . A replacement device was shipped to the customer on August 11, 2008.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 1 unit
- Distribution
- Nationwide Distribution: to one account in Arkansas.
- Date initiated
- 2008-08-07
- Date posted
- 2010-11-22
- Date terminated
- 2010-12-01
- Location
- Seattle, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PHILIPS HEARTSTART FRX DEFIBRILLATOR, MODEL 861304 (K050004) | Philips Medical Systems | 2005-02-25 |