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U.S. Department of Health and Human Services

Safety

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BiPAP Focus Non-Invasive Ventilator System, Respironics California

Audience: Respiratory healthcare professionals, risk managers

Respironics California, Inc. and FDA notified healthcare professionals of a Class I recall of the BiPAP Focus Non-Invasive Ventilator System, model number PCM120PS18-2315P. This device is used by healthcare professionals to treat adult patients who have advanced lung disease and/or have difficulty breathing. Power supply failures have occurred on some ventilators. This product was distributed from August, 2006 through April 11, 2008. Customers/distributors may contact Respironics U.S. Customer Service at 1-877-387-3377 or Respironics International Customer Service at 1-724-387-4000.

[07/09/2009 - Recall Notice - FDA]