Medtronic Division Recalls DefibrillatorsSep 17, 2009 | Parker Waichman LLP
Physio-Control, Inc., a division of Medtronic, Inc., is recalling LifePak CR Plus Automated External Defibrillators (AED). The Food & Drug Administration (FDA) has deemed this a Class I recall.
This recalled device is used by emergency or medical personnel, by others who have completed CPR AED training courses, or the public at large. It is intended to treat patients in cardiac arrest. The device analyzes an unconscious patient’s heart rhythm and instructs the user to press a button that delivers an electrical shock to the heart to restore a normal heart rhythm.
According to the recall notice, an extremely humid environment may cause the LifePak CR Plus AED to improperly analyze the rhythm correctly and may cause the device to delay or fail to delivery therapy.
The recalled LifePak CR Plus AEDs were manufactured and distributed from July 9, 2008 through August 19, 2008. Devices with the following serial numbers are affected by this recall:
37026963, 37026983, 37026984, 37026997, 37027002, 37027008, 37027039, 37027040, 37027049, 37027053, 37027063, 37027065, 37027066, 37027070, 37027071, 37027073, 37027075, 37027090, 37027099, 37027105, 37027122, 37027197, 37027529, 37027569, 37031393, 37037850, 37037893, 37037986, 37038002, 37038211,37038365, 37135986, 37154526, 37154638
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 injury or death.