Recall Z-0063-2010 ยท MKJ Automated External Defibrillators (Non-Wearable)
Philips Medical Systems
Heartstart FR2+ automated external defibrillator Models M3860A and M3840A are equipped with an ECG Module. M3860A is under the Philips label and M3840A is under the Laerdal label.
| Date | Dec 8, 2009 (initiated Oct 1, 2009) |
| Status | Terminated |
| Reason | A potential exists for a component failure, which, if it occurs, could result in the inability to deliver therapy. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 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, Japan, Jordan, Lebanon, Malaysia, Mexico, Netherlands, Norway, Portugal, Singapore, South Africa, Spain |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051632 | PHILIPS HEARTSTART FR2+ AUTOMATED EXTERNAL DEFIBRILLATOR, MODELS M3860A, M3861A, M3840A, M3841A Philips Medical Systems, Oct 5, 2005 |