The United States Food & Drug Administration has announced a Class I recall of LIFEPAK 15 monitor/defibrillator. The company that makes the medical device said that the device contains an internal defect that can cause the product to turn off by itself, to turn off and on, or to turn on by itself. This defect could put patients in grave danger.

Physicians using the device should check the serial number on their device and know that the products affected by the defective medical device recall were manufactured and distributed between March 26, 2009 and December 15, 2009. Another Class I recall was issued last year for a similar device made by the same company: the LIFEPAK CR Plus automated external defibrillators.

Class I recalls are the most urgent and serious type of FDA recalls – Class I drug and medical device recalls involve products that could lead to serious harm, injury, or even death.