Respironics PLV Continuum Ventilator (PLVC I)
Audience: Respiratory healthcare professionals, hospital risk managers and biomedical engineers
[Posted 05/05/2006] Respironics and FDA notified healthcare professionals about the Class 1 recall of this device, a mechanical ventilator used to control or assist breathing. The ventilator is intended for home, institutional and portable settings and may be used for invasive as well as noninvasive ventilation. A design flaw can cause lead wires in the air flow valve to break during use. When this happens the ventilator stops providing mechanical ventilation. Customers should safely transition patients in their care from the PLV Continuum Ventilator onto other comparable patient support devices. If customers do not have a suitable ventilator to use for their patients, they should contact Respironics at 760-918-7328 to make suitable substitute arrangements.
[May 05, 2006 -Class 1 Recall - FDA]