Recalls

FDA issues Class 1 recall on LIFEPAK monitors, defibrillators

The LIFEPAK 15 monitor/defibrillator, a device used by trained medical personnel in emergency care settings to monitor patient heart rhythms and to treat patients experiencing cardiac arrest, is being recalled by the Food and Drug Administration (FDA) because the devices may unexpectedly shut off and on by themselves. The recall was given a Class 1 status, which is the FDA’s most serious type of recall and involves situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

The recalled LIFEPAK devices were manufactured between March 26, 2009 and December 15, 2009, and distributed between March 27, 2009 and December 15, 2009. The recalled devices were found to have a defect that may cause them to power off and on by themselves, power off then not turn on, power off by themselves requiring the operator to turn them back on, and stay powered on and not allow themselves to be turned off.

Physio-Control, Inc. informed its LIFEPAK customers by letter advising them to keep the device in service and to test it according to operating instructions. Local service representatives began scheduling service visits to be completed within 60 days of the letter. Healthcare professionals and consumers are encouraged to report any adverse reactions or quality problems experienced by this or any other device to the FDA MedWatch Adverse Event Reporting program at www.FDA.gov/MedWatch.