Software Glitch Leads to Class I Ventilator Recall

FDA says 248 Hamilton Medical AG ventilators were involved in the recall.

Nancy Crotti

A software glitch has prompted the recall of a Hamilton Medical AG ventilator, and the recall is serious enough that FDA has designated it as Class I.

Customers reported that the display screen on the Hamilton-G5 ventilator equipped with software versions V2.40 and V2.41 could freeze, and that they could no longer operate the device, according to the FDA's announcement of the Class I designation.

FDA listed 248 ventilators in commerce.

The family-owned company, based in Bonaduz, Switzerland, notified their customers by letter in March, and had a software fix already available. FDA opted to announce the Class I recall on July 10. AClass I designation means the issue could cause serious adverse health consequences or even death if not corrected.

Hamilton's T1 ventilators with software versions 1.1.2 and lower were recalled in January 2013. The problem then may have caused unexpected high internal oxygen consumption while ventilating small pediatric patients with high airway resistance and low lung function.

Faulty ventilator software has plaguedCovidien as well. A 2013 recall revealed a software defect involving models of Covidien's Puritan Bennett 840 Series Ventilator manufactured April30, 1998 to March 12, 2010 and distributed August 1, 2008 to October 31, 2010. Affected models had a software glitch that triggered a diagnostic code that would require patients to have to breathe on their own. The company notified customers in December 2013.

Chris Newmarker is senior editor of Qmed and MPMN. Follow him on Twitter at @newmarker.

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