Defibtech Recalling 65,000 U.S. AEDs
The class I recall announced by the Food and Drug Administration is a worldwide voluntary recall of Lifeline AED and ReviveR AED units shipped with 2.004 software or earlier.
Owners of at least 65,885 automated external debrillators distributed in the United States by Defibtech LLC are receiving letters notifying them of a voluntary recall. The DU-100 series AEDs were sold under the Lifeline AED and ReviveR AED brand names and potentially can fail to shock a patient in two scenarios, according to FDA, which announced the class I recall on April 29. A letter from Defibtech CEO Glenn W. Laub, M.D., to customers was dated March 11, however.
One scenario, affecting 65,885 AEDs, causes the devices' charge to be cancelled in preparation for a shock. The letter says 11 instances of this happened during patient care, and when a shockable rhythm was detected, the units delivered at least one shock. More than 70 percent of the time, they delivered two or more, it says. The second scenario, affecting 6,973 AEDs distributed in the United States, causes the charge to be cancelled prior to the shock in very high humidity conditions. This happened two times during patient use "in environments of greater than 95% relative humidity or condensing conditions," Laub writes. He says field data show that the odds of the first problem happening are less than one in 400,000 per month for any given AED, and the odds of the second are one in 250,000.
"Because both of these conditions occur very rarely, it is recommended that you keep your AED in service until you have performed the software upgrade," he adds.
Ray Valek, a spokesman for the company, said May 3 that he believes most customers have not yet received the field software upgrade that the letter describes; it asks them to check the serial number of their AED(s) and request the upgrade if they own an affected unit. FDA typically places AED recalls in the class 1 category, the highest possible, which FDA defines as "a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death."
"In this case, it's more of a corrective field action," Valek said. "We're sending out software to correct it."
The software upgrade will upgrade the customers' AED(s) to the 2010 American Heart Association guidelines, according to Laub's letter.