FDA Issues Class I Recall of LIFEPAK CR Plus Defibrillators

Disclosures

September 16, 2009

September 16, 2009 (Washington, DC) — The Food and Drug Administration issued a class I recall of the LIFEPAK CR Plus automated external defibrillators (Physio-Control, Redmond, WA) [1]. The recall affects models 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," according to the FDA.

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. The serial numbers of affected models are available on the FDA's website. Adverse events or quality problems with the product should be reported to the agency's MedWatch adverse-event online reporting program.

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