Reported Jul 9, 2014 · Terminated
DeVilbiss Model DV5x Series CPAP units. For use in treating Obstructive Sleep Apnea (OSA) by means of application of…
DeVilbiss Healthcare LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: DeVilbiss Healthcare LLC · 100 Devilbiss Dr · Somerset, PA · 15501-2125
Is this the product you have?
- 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.
- Lot codes and dates
- Model #serial numbers
DV51D-HHDV53D-HHDV53D-HH-SDV54D-HHDV54D-HH-SDV55D-HHDV55D-HH-SDV55D-SDV57D-HH
1,809 of 1,809 codes
KD012316JD034349JD034384JD034389HD070335HD070339HD070352HD070357HD070377HD070379HD070395HD071128HD071138HD071154HD071278HD070474HD070736JD034560JD034566HD070219HD070162HD070172HD070174HD070178HD070182HD070827HD070961HD071003HD071004HD071007HD071009HD071020HD071021HD071022HD071030HD071032HD071033HD071040HD071043HD071045HD071048HD071057HD071058HD071059HD071062HD071063HD071064HD071065HD071069HD071072JD034492JD034497JD034504JD034506JD034507JD034540JD034543JD034553JD034554JD034555
- Model #
- Amount recalled
- 1809
Where it was sold
- Nationwide
Why it was recalled
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".
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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