Defibrillators Recalled
The Food and Drug Administration and Medtronic Inc have announced a recall of some of Medtronic’s Lifepak heart monitor and external defibrillators. The recall was caused by concerns that the devices can unexpectedly turn on and off.
The FDA said it considered the recall of Medtronic's Lifepak 15 emergency heart devices a Class I recall, the most serious possible. It said the defect is serious enough to cause harm or death.
Lifepak devices are used in emergency settings by hospitals, the military and others to help the heart beat normally and to monitor patients.
The recall affects Lifepak 15 devices made before Dec. 16, 2009. No patients have been harmed to date.
The defibrillators were manufactured with an internal component that could cause an electrical short that leads to the device turning off/on by itself or a power loss. A loss of power could delay or prevent delivery of defibrillation therapy.
