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FDA Hits Philips Respironics With Class I Recall Over Ventilators

FDA has determined that the voluntary notification that Philips Healthcare sent providers about its Respironics V60 ventilator is a Class I recall.

FDA has classified the notification that Philips Respironics, a manufacturer of respiratory and sleep aids, sent to healthcare providers over its ventilators a Class I recall.

Specifically, the recall affects the Respironics V60 ventilator, which provides continuous or intermittent breathing support to children weighing 44 pounds or greater, as well as to adult patients. Respironics found that because of a software glitch in the power management board assembly, if a component fails on the assembly, it could cause the ventilator support to be lost without any audible alarm that serves as an alert.

Philips Healthcare sent a letter to healthcare providers on June 4 saying that the problem affected V60 ventilators sold between November 16, 2009 and March 28 of this year.

The company is providing a free update as well as a replacement of the power management board assembly software and once that is done, the product can continue to be used. Users of the product are urged to contact a Philips representative.

-- By Arundhati Parmar, Senior Editor, MD+DI

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