DeVilbiss Healthcare LLC recalls DeVilbiss Model DV5x Series CPAP units. For use in treating Obstructive Sleep Apnea (OSA) by means of application of pos

Recalled July 9, 2014 · FDA recall Z-1949-2014 · DeVilbiss Healthcare

Hazard

A limited number of DV5x Series CPAP units were manufactured and shipped without the serial number programmed into the unit, causing the unit serial number on LCD display to appear as "RUN-TEST". · FDA Class III

Units

1809

Sold at

Worldwide Distribution - USA (nationwide) and the countries of Colombia, Honduras, Iran, Thailand and Uruguay.

Description

A limited number of DV5x Series CPAP units were manufactured and shipped without the serial number programmed into the unit, causing the unit serial number on LCD display to appear as "RUN-TEST".

Product

DeVilbiss Model DV5x Series CPAP units. For use in treating Obstructive Sleep Apnea (OSA) by means of application of positive air pressure. Used in home and clinical environments.

Manufacturer(s)

DeVilbiss Healthcare LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →