Philips Heartstart FRx 의 리콜

Recall

55579

Class 2

Z-1915-2010

2010-04-30

2010-06-28

Terminated

United States

2012-12-10

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91190

Seventeen aeds failed production line testing (final acceptance test).

The firm notified U.S. distributors on 4/30/2010 via phone call and e-mail to obtain consignee location information. A website providing information was activated on 4/30/2010. On 5/3/2010 Urgent Medical Device Recall letters, dated April 29, 2010 were sent to direct customers in the US. The letters explained the reason for the recall and Customers were asked to verify that they have the product subject to recall. Replacement AEDs will be provided at no charge to the customer. Field Safety Notices were attached to the letters and provided a list of actions for customers to take. Customers should check the serial number on their devices against the list provided, contact Philips Healthcare to arrange for replacement, and ensure that necessary staff are aware of the recall. For further information and support, Philips Healthcare should be contacted at 1-800-263-3342.