Date Recall |
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. |
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 |
FDA District: |
Los Angeles |
FDA Comments: |
|
For more information about this recall, please see the company’s press release on the Respironics website. | |
|
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. |
Updated May 5, 2006
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