Medical Devices
Respironics California Inc., BiPAP Focus Non-Invasive Ventilator System
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Recall Class:
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Class I |
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Date Recall
Initiated: |
September 22, 2008 |
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Product:
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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. |
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Use:
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This device is used by healthcare professionals to treat adult patients who have advanced lung disease and/or have difficulty breathing. |
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Recalling Firm:
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Respironics California, Inc. 2271 Cosmos Court Carlsbad, California 92011 |
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Reason for Recall:
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Power supply failures have occurred on some ventilators. A power surge may exceed the power supply capacity, causing the power supply to lose power. |
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Public Contact:
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Customers/distributors may contact Respironics U.S. Customer Service at 1-877-387-3377 or Respironics International Customer Service at 1-724-387-4000. |
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FDA District:
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Los Angeles |
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FDA Comments:
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On September 22, 2008, the company sent a letter to their customers and distributors with the affected devices informing them of the potential problem. The letter included instructions for device removal and replacement, and return of the company’s response form. Class 1 recalls are the 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. Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of these products to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.
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