FDA-Device2014-07-09Class III
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.
DeVilbiss Healthcare LLC
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".
Sold states
Worldwide Distribution - USA (nationwide) and the countries of Colombia, Honduras, Iran, Thailand and Uruguay.
Affected count
1809
Manufactured in
100 Devilbiss Dr, Somerset, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1949-2014Don't want to check this manually?
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