Class 1 Medical Device Recalls - Respironics PLV Continuum Ventilator (PLVC I)

Date Recall
Initiated:

March 20, 2006

Product:

Respironics PLV Continuum Ventilator (PLVC I)

Use:

The PLVC I is a mechanical ventilator used to control or assist breathing. The ventilator is intended for home, institutional and portable settings and may be used for invasive as well as noninvasive ventilation. It is not intended for use as an emergency transport ventilator.

Recalling Firm:

Respironics California, Inc.
2271 Cosmos Ct.
Carlsbad, CA 92009-7517

Reason for Recall:

A design flaw can cause lead wires in the air flow valve to break during use. When this happens the ventilator stops providing mechanical ventilation.

Public Contact:

Mary Funk
Regulatory Affairs Manager
Respironics, California, Inc.
2271 Cosmos Ct.
Carlsbad, CA 92011
760-918-7328

FDA District:

Los Angeles

FDA Comments:

• Respironics California, Inc. mailed notification letters to customers on March 20, 2006, instructing them to quarantine all PLV Continuum Ventilators in their possession, and to not use the ventilators to treat patients.
• Respironics Customer Service representatives will contact customers to arrange for the return of all PLV Continuum Ventilators.
• Customers should safely transition patients in their care from the PLV Continuum Ventilator onto other comparable patient support devices.
• If customers do not have a suitable ventilator to use for their patients, they should contact Respironics to make suitable substitute arrangements.
• Customers may contact Respironics at 760-918-7328.
  

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.