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Class I Recall for BiPAP Ventilators

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A Class I recall of  BiPAP Focus Non-Invasive Ventilator Systems has been issued by Respironics California. According to the recall notice, power supply failures have occurred on some ventilators.  A power surge may exceed the power supply capacity, causing the power supply to lose power.

The BiPAP Focus Non-Invasive Ventilator System is used by healthcare professionals to treat adult patients who have advanced lung disease and/or have difficulty breathing.   If there is a failure of power during operation, the BiPAP Focus will switch to back up battery power, which can provide up to 50 minutes of operation on a fully charged battery at default settings. Audible and visual alarms will alert clinicians to the loss of power, so that appropriate corrective actions can be taken.

In the unlikely event that alarms do not prompt the clinical team to provide alternative respiratory support before the battery is exhausted, patients may be at risk for serious injury or death due to low levels of oxygen or high levels of carbon dioxide in the blood. These risks apply primarily to patients who cannot breathe on their own, although it should be noted that the labeling for the BiPAP Focus Ventilator specifically states it is not intended for use on such patients.

The recall involves BiPAP Focus Non-Invasive Ventilator System, model number PCM120PS18-2315P.  This product was manufactured prior to March, 2008 and distributed from August, 2006 through April 11, 2008.  The devices were distributed in the United States, Canada, Europe, Latin America, Africa and Asia Pacific.

Class 1 recalls are the Food & Drug Administration’s (FDA) most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.

Respironics has received several reports of device failure; however, there have been no reports of injury.

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