The Food and Drug Administration (FDA) recently announced a Class 1 recall of Maquet Getinge Group's battery modules for use in its SERVO-i ventilator systems. "Some battery modules distributed after Jan. 31, 2010, have a shorter battery run time than expected," the FDA states. "This can result in unexpected ventilator shutdowns, which can result in serious adverse health consequences, including death." Customers are instructed to change the power source to AC and replace the battery modules if either "low battery voltage" or "replace battery" messages are displayed. The SERVO-i system is used to treat and monitor patients ranging from neonates to adults with respiratory failure or insufficiency.
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Battery modules for ventilator systems recalled by FDA
June 2013 Checklist
June 1, 2013