Physio-Control Inc., LIFEPAK 15 Monitor/Defibrillator
Recall Class: Class I
Date Recall Initiated: March 4, 2010
Product(s): LIFEPAK 15 Monitor/Defibrillator
See under Useful Links to search for affected devices by serial number.
The serial number is located on the underside of the device.
These devices were manufactured between March 26, 2009 and December 15, 2009 and distributed between March 27, 2009 and December 15, 2009.
Use: The LIFEPAK 15 monitor/defibrillator is designed for use by trained medical personnel in out-of-doors and indoor emergency care settings to monitor patient heart rhythms and to treat patients experiencing cardiac arrest.
11811 Willows Road NE
Redmond, Washington 98052-2003
Reason for Recall: There is a potential for the device to unexpectedly:
- Power Off then On by itself.
- Power Off then NOT turn On.
- Power Off by itself requiring the operator to turn it back On.
- Stay powered On and not allow itself to be turned Off.
Public Contact: Physio-Control Technical Support at
1-800-442-1142 – option 5, Monday – Friday between 6:00 A.M. and 4:00 P.M. (Pacific Time).
More information available at http://www.physio-control-notices.com/LP15pcba
FDA District: Seattle
FDA Comments: On March 4, 2010, the company informed customers by letter advising them to keep the device in service and to test their devices according to the operating instructions. The company stated that local service representatives are scheduling service visits within 60 days. Customers were asked to forward the Physio-Control notice to all their responsible parties.
Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.