FDA Device recall Z-1949-2014
DeVilbiss Model DV5x Series CPAP units
- FDA Device
- Class III
- terminated
- Published 2014-07-09
On 2014-07-09 the FDA classified a Class III recall of DeVilbiss Model DV5x Series CPAP units by Devilbiss Healthcare, citing 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 appea….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1949-2014 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2014-05-13 |
| Published | 2014-07-09 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Devilbiss Healthcare |
| Distribution | US |
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.
Reason
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".
Identifiers
| code_info | Model # DV51D-HH DV53D-HH DV53D-HH-S DV54D-HH DV54D-HH-S DV55D-HH DV55D-HH-S DV55D-S DV57D-HH serial numbers…Model # DV51D-HH DV53D-HH DV53D-HH-S DV54D-HH DV54D-HH-S DV55D-HH DV55D-HH-S DV55D-S DV57D-HH serial numbers KD012316 JD034349 JD034384 JD034389 HD070335 HD070339 HD070352 HD070357 HD070377 HD070379 HD070395 HD071128 HD071138 HD071154 HD071278 HD070474 HD070736 JD034560 JD034566 HD070219 HD070162 HD070172 HD070174 HD070178 HD070182 HD070827 HD070961 HD071003 HD071004 HD071007 HD071009 HD071020 HD071021 HD071022 HD071030 HD071032 HD071033 HD071040 HD071043 HD071045 HD071048 HD071057 HD071058 HD071059 HD071062 HD071063 HD071064 HD071065 HD071069 HD071072 JD034492 JD034497 JD034504 JD034506 JD034507 JD034540 JD034543 JD034553 JD034554 JD034555 HD071068 JD034316 JD034317 JD034327 JD034328 JD034329 JD034330 JD034331 JD034332 JD034333 JD034334 HD070167 HD070171 HD070177 HD070190 HD070191 HD070198 HD070206 HD070212 HD070223 HD070225 HD070248 HD070249 HD070279 HD069902 HD069903 HD069906 HD069907 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1949-2014%22
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