Audience: emergency medical personnel, consumers
April 22, 2010 — The FDA notified health care professionals of a class I recall of LIFEPAK 15 Monitor/Defibrillator manufactured and distributed between March 26, 2009 and December 15, 2009. 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; and
- stay powered on and not allow the operator to turn the device off.
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.
April 22, 2010 — FDA recall notice