Maquet’s Class I ventilator battery recall affects 90k units

May 15, 2013 by Sony Salzman

The FDA warns healthcare providers of a Class I recall of some of Maquet Cardiovascular's malfunctioning battery units.


A Class I recall, reserved for serious patient harm, was issued over battery units produced by Getinge (PINK:GETI B) subsidiary Maquet Cardiovascular.

The batteries, which power ventilators used during intra-hospital transport of patients from neonates to older adults, have a shorter lifetime than expected, meaning the ventilators may shut down prematurely.

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The Wayne, N.J.-based medical device maker sent customers a field safety notice letter on March 7, 2013, instructing healthcare providers to switch to an AC power source as soon as a "low battery" notice appears on the devices. The recall applies to 90,000 battery modules manufactured between February 2010 and November 2012, according to the FDA recall notice.