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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. 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.
Read the complete MedWatch Safety summary, including a link to the FDA Recall notice, at:
www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm171242.htm
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420
GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420
