FDAFDA · Food and drugs·Recall number Z-1949-2014
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.
Published July 9, 2014 · Recall initiated: May 13, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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".
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- DeVilbiss Healthcare LLC
- Distributor
- Worldwide Distribution - USA (nationwide) and the countries of Colombia, Honduras, Iran, Thailand and Uruguay.
- Lot
- 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 HD070533 HD070534 HD070545 HD070548 HD070563 HD070598 HD070605 JD034598 JD034599 JD034601 JD034603 JD034604 HD070724 HD070749 HD070756 HD070758 HD070760 HD070763 HD070767 HD070779 HD070781 HD070783 HD070787 HD070797 JD034569 JD034571 JD034576 JD034578 JD034586 JD034588 JD034591 JD034592 JD034597 HD069969 HD070722 HD070728 HD070733 HD070761 HD070784 JD034519 JD034602 JD034609 JD034613 JD034614 kd014347 HD069922 HD069905 HD069916 HD069917 JD034156 JD034158 JD034159 JD034163 JD034165 JD034185 JD034186 KD014349 KD014350 JD034209 JD034212 JD034231 JD034235 JD034239 JD034242 JD034584 JD034587 JD034589 JD034568 JD034581 JD034582 HD070283 HD070301 JD034161 JD034171 HD069927 HD069929 HD069930 HD069932 HD069949 HD069951 JD034211 JD034226 KD014329 HD070482 HD070483 HD070500 HD070556 HD070719 HD070720 HD070791 HD070800 HD070828 ID039134 ID039150 ID039167 KD014117 JD034402 KD014229 JD034154 JD034155 JD034160 JD034183 JD034188 JD034189 JD034190 JD034192 JD034193 JD034197 JD034221 JD034224 JD034229 JD034230 JD034232 JD034233 JD034162 JD034217 JD034236 JD034237 JD034240 JD034241 JD034244 JD034391 JD034392 JD034393 JD034394 JD034398 JD034405 JD034409 JD034410 JD034411 JD034412 JD034413 JD034414 KD014261 KD014301 KD014302 KD014307 KD014310 HD070617 HD070620 HD070626 HD070630 ID039143 HD070995 HD070802 HD070805 HD070813 HD070819 HD070825 HD070919 HD069941 HD070948 HD070773 HD070790 HD070864 HD070869 HD070947 HD070834 HD070836 HD070852 HD070859 HD070949 HD070950 HD070527 HD070635 HD070636 HD070637 HD070638 HD070639 HD070640 HD070591 HD070606 HD070623 HD070633 JD034500 JD034508 JD034509 JD034512 JD034521 JD034523 JD034524 JD034605 JD034610 JD034611 KD014187 KD014188 KD014189 KD014260 KD014263 KD014268 KD014270 KD014285 MD003233 MD003244 HD070962 HD070966 HD070968 HD070969 HD070990 JD034498 JD034499 JD034533 JD034544 HD070976 HD070977 HD070982 HD070985 HD071100 HD071102 HD071103 HD071104 HD071105 HD071106 HD071107 HD071111 HD071112 HD071113 HD071114 HD071115 HD071117 HD071118 HD071119 HD071120 JD034418 JD034419 JD034423 KD014348 KD014124 HD070410 HD070373 HD070388 JD034202 JD034206 JD034207 JD034223 JD034757 JD034758 JD034761 JD034762 HD070988 HD071084 JD034627 JD034629 JD034630 JD034658 JD034666 JD034671 JD034749 JD034752 HD069895 HD069896 HD069897 HD069898 HD069899 HD069928 HD069931 HD069933 HD069934 HD069937 HD069939 HD069942 HD069955 HD069957 HD069966 HD069993 HD069999 HD070001 JD034361 JD034364 HD070502 HD070503 JD034399 JD034401 HD070741 HD070765 HD070768 HD070777 HD070785 HD070788 JD034434 JD034452 HD070612 HD070613 HD070973 HD069936 HD069946 HD069948 HD069952 HD069959 HD069961 HD069963 HD069972 HD069994 HD069997 HD070569 HD070570 HD070571 HD070572 HD070573 HD070574
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.