• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Medical Devices

  • Print
  • Share
  • E-mail

Respironics California Inc., BiPAP Focus Non-Invasive Ventilator System

Recall Class:
Class I
Date Recall
Initiated:
September 22, 2008
Product:

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.

Use:
This device is used by healthcare professionals to treat adult patients who have advanced lung disease and/or have difficulty breathing.
Recalling Firm:
Respironics California, Inc.
2271 Cosmos Court
Carlsbad, California 92011
Reason for Recall:
Power supply failures have occurred on some ventilators. A power surge may exceed the power supply capacity, causing the power supply to lose power.
Public Contact:
Customers/distributors may contact Respironics U.S. Customer Service at 1-877-387-3377 or Respironics International Customer Service at 1-724-387-4000.
FDA District:
Los Angeles
FDA Comments:

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.

  • Online: MedWatch
  • Regular Mail: use postage-paid FDA form 3500
    Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
  • FAX: 1-800-FDA-0178