A Medical Device Daily
Respironics (Murrysville, Pennsylvania) on Friday reported its voluntary recall of 269 ventilators representing all models and serial numbers of the PLV Continuum Ventilator. The company said the recall is the result of reports that the ventilator may suddenly stop providing mechanical ventilation and could result “in serious injury or death.”
It directed customers to “quarantine” all PLV Continuum Ventilators and to use other ventilator models. In the case of customers not have a suitable substitute ventilator, Respironics said it will loan them a comparable unit.
The PLV Continuum Ventilator is used to provide mechanical ventilation for pediatric and adult patients who weigh at least 11 lbs. (5kg). The device is intended for use at home, in an institution, or as a portable ventilator. The ventilators have been distributed in the U.S., Australia, Argentina, Canada, Japan, Hong Kong, Netherlands, Saudi Arabia, and Taiwan. Respironics said it notified distributors, sales personnel and customers of the recall via letter dated March 20 and that it is contacting customers to arrange return of the devices.
Respironics said that it reported the recall to the FDA which classified it as Class I on April 27.
Respironics provides products and programs serving the sleep and respiratory markets.