Philips HeartStart FRx 861304 Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 9812
FDA device recall Z-0642-2013 · posted 2013-01-04 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Reason for recall
- Philips determined that it is important to clarify information in the Owner's Manual and keep customers informed about the maintenance of their FRx (models 861304 and 861305), OnSite (models M5066A and M5067A), or HeartStart Home (model M5068A) automated external defibrillators (AEDs) shipped between December 2005 and July 2012. Philips had determined there is a need to emphasize the importance o
- Action taken
- Philips Healthcare sent an Emergency Care and Resuscitation letter Customer Information Letter dated July 26, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to contact their Philip's representative to obtain the tools and information they need to ensure that their device is functioning properly. For questions regarding this recall, please call AED Recall Support at 1-800-263-3342 (Option 6).
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 201,598
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of Japan and Malaysia.
- Date initiated
- 2012-07-26
- Date posted
- 2013-01-04
- Date terminated
- 2020-09-21
- Location
- Bothell, 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 |