Heartstart FR2+ automated external defibrillator models M3861A and M3841A are NOT equipped with the ECG Module. Model M3861A is under the Philips label and M3841A is under the Laerdal label.
Recall
- Recall Number
- Z-0062-2010
- Event Number
- 53383
- Firm
- Philips Medical Systems
- FEI Number
- 1000524572
- Product Code
- MKJ
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- October 1, 2009
- Posted
- December 8, 2009
- Terminated
- September 27, 2013
- Address
- 2301 5th Ave, Ste 200, Seattle, WA, 98121
Description
Heartstart FR2+ automated external defibrillator models M3861A and M3841A are NOT equipped with the ECG Module. Model M3861A is under the Philips label and M3841A is under the Laerdal label.
A potential exists for a component failure, which, if it occurs, could result in the inability to deliver therapy.
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.
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, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, and United Arab Emirates.
see Z-0063-2010