Heartstart FR2+ automated external defibrillator Models M3860A and M3840A are equipped with an ECG Module. M3860A is und
FDA device recall Z-0063-2010 · posted 2009-12-08 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems
- Reason for recall
- A potential exists for a component failure, which, if it occurs, could result in the inability to deliver therapy.
- Action taken
- On September 28, 2009 Philips issued a nationwide press release. On October 1, 2009 the firm issued notification letters to consignees arranging for the return and replacement of the affected units. The firm also set up a page on their website with a serial number look-up tool. For further information or support concerning this issue, customers are asked to contact Philips at 1.800.263.3342 or visit www.philips.com/FR2PlusAction for the serial number look-up list, answers to frequently asked questions, directions for the battery insertion test, and the replacement AED selection form.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 5,808
- Distribution
- Domestic and Worldwide distribution to: United States, Canada, Australia, Austria, Bulgaria, China, Finland, France, Germany, Gibraltar, Great Britain, Hong Kong, India, Indonesia, Ireland, Italy, Jap
- Date initiated
- 2009-10-01
- Date posted
- 2009-12-08
- Date terminated
- 2013-09-27
- Location
- Seattle, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PHILIPS HEARTSTART FR2+ AUTOMATED EXTERNAL DEFIBRILLATOR, MODELS M3860A, M3861A, M3840A, M3841A (K051632) | Philips Medical Systems | 2005-10-05 |