Recalled all units of one of its ventilator models because the machine could stop without warning. Respironics Inc., a maker of respiratory products, said Friday it voluntarily recalled all units of one of its PLV Continuum ventilators because the machine could stop without warning.
The company said it was recalling all 269 of its PLV Continuum ventilators because an analysis of returned units revealed that one of the internal flow valves on the machine could fail, and cause serious injury or death.
Food and Drug Administration classified the action as a Class I recall
Respironics said it has not received any reports that this has happened in the field. The company alerted all customers in a March 20 letter not to use the ventilator until the problem has been corrected.
The Food and Drug Administration classified the action as a Class I recall, the most serious kind, on April 27. Class I recall follows stricter implementation of the laws governing this kind of medical devices. In fact, many companies have been sued and fined for various offenses.