Company Issues Worldwide Recall of Defibrillators
Problem with electrical connection may cause device to fail
TUESDAY, July 11 (HealthDay News) -- MRL Inc., of Buffalo Grove, Ill., has initiated a voluntary worldwide recall of its PIC50 External Monitor/Defibrillators. The 1,184 devices concerned were manufactured between February 2002 and October 2004.
Due to an intermittent electrical connection, the devices may display an error message (DEFIB COMM ERROR), which could delay or prevent the device from working.
So far there have been 18 complaints lodged with the company, accounting for 1.5 percent of the 1,184 devices that are under recall. Patient resuscitation was delayed in two instances. The error does not affect any other devices. While 673 of the devices were sold within the United States, the remaining 511 were sold in other countries. All customers were notified of the recall by registered mail.
The company informed the U.S. Food and Drug Administration, which posted the recall on its Web site. The FDA considers this a Class I recall, meaning there is "reasonable probability that the use of or exposure to the product will cause serious adverse health consequences or death," according to a company statement.