The device may have problems powering on and off, which may result in serious adverse events
MONDAY, April 26 (HealthDay News) -- The U.S. Food and Drug Administration has alerted health care professionals of a Class I recall of Physio-Control Inc.'s LIFEPAK 15 Monitor/Defibrillator, distributed between March 26 and December 15, 2009, as the device may have issues with powering on and off.
The LIFEPAK 15 Monitor/Defibrillator is used to monitor heart rhythms and treat patients experiencing cardiac arrest in emergency care settings. The reasons for the recall include the potential for the device to unexpectedly power off and then turn on by itself, or power off and then not turn on again. In addition, the device may power off by itself, which requires that it be manually turned on again, or stay powered on without allowing itself to be switched off.
The company advised customers via letter on March 4, 2010, to continue to use their devices and to test them using the operating instructions. The company also said that service representatives would be scheduling service visits within two months.
"Class I 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," the FDA said in its recall announcement. "Health care professionals are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program."