News

9/16/2009 - IMEP eAlert: FDA Class I Recall: Lifepak CR Plus AED

LIFEPAK CR Plus Automated External Defibrillators (Physio-Control, Inc)

FDA notified healthcare professionals of a Class I recall of certain LIFEPAK CR Plus Automated External Defibrillators (AED) manufactured and distributed from July 9, 2008 through August 19, 2008. An extremely humid environment may cause the affected devices to improperly analyze the heart rhythm and may cause the device to delay or fail to deliver therapy.

Physio-Control Customer Care
1-800-442-1142, 6 AM through 4 PM Pacific Time

Physio-Control Inc., LIFEPAK CR Plus Automated External Defibrillator (AED)

Only the Physio-Control LIFEPAK CR PLUS AEDs with the serial numbers below are affected by this recall.

Serial Numbers
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

The serial number is located on the underside of the device.

The AEDs were manufactured and distributed from July 9, 2008 through August 19, 2008.

Read the complete MedWatch 2009 Safety summary, including a link to the Class 1 recall notice, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm182496.htm

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