FDAnews Device Daily Bulletin

MRL, FDA ANNOUNCE CLASS I RECALL FOR ANOTHER BRAND OF WELCH ALLYN AEDS

July 11, 2006
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MRL has issued a worldwide Class I recall of 1,184 Welch Allyn PIC50 automated external defibrillators (AEDs) manufactured between February 2002 and October 2004, the FDA said July 10.

The company has received 18 complaints related to the PIC50, which may display a "Defib Comm Error" that can delay therapy and result in a failure to resuscitate the patient, MRL said July 7. The problem has been attributed to an intermittent electrical connection within the device. Most of these errors are detected by an automatic self-test when the PIC50 is powered, the firm said.

This most recent action comes on the heels of a Class I recall posted by the FDA June 15 for MRL's Welch Allyn AED 20 defibrillators manufactured from April through October 2003.

To view MRL's press release on the PIC50 recall, go to www.fda.gov/oc/po/firmrecalls/MRL07_06.html (http://www.fda.gov/oc/po/firmrecalls/MRL07_06.html).