Retiro De Equipo (Recall) de Device Recall DeVilbiss

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por DeVilbiss Healthcare LLC.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
  • ID del evento
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Ventilator, non-continuous (respirator) - Product Code BZD
  • Causa
    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".
  • Acción
    DeVilbiss Healthcare sent an Urgent: Medical Device Correction notice dated May 13, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. What to do if you have an affected DV5x Series CPAP unit: 1. Verify your inventory of DV5x Series CPAPs and isolate any units that are on the included serial number list, these units will need to have the serial number corrected. 2. Please contact DeVilbiss Healthcare Customer Service to either request a Sales Representative to correct the issue on site or return the unit back to DeVilbiss to be corrected. 3. If you have already distributed any DV5x Series CPAPs included in this serial number list to end users, a patient communication has been included with this notification - a. Insert your contact information at the bottom of the "User Medical Device Correction Letter" included in this notice. b. Forward a copy of the "User Medical Device Correction Letter'' to each user to whom you have provided an affected DV5x Series CPAP unit. If you have one or more of the affected DV5x Series CPAP unit in your possession (as identified in the serial number list) and have any questions regarding the information provided in this communication, please contact DeVilbiss Healthcare Customer Service at 1-800- 338-1988 from 8:00AM-5:00PM EST. [Note: If you have already spoken with a DeVilbiss Healthcare Representative about this issue, there is no need to call unless you have further questions.]


  • Modelo / Serial
    Model # DV51D-HH DV53D-HH DV53D-HH-S DV54D-HH DV54D-HH-S DV55D-HH DV55D-HH-S DV55D-S DV57D-HH  serial numbers 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0540 HD070554 HD070557 JD034382 JD034383 JD034747 JD034748 JD034750 JD034764 JD034767 JD034387 KD014231 JD034238 JD034243 JD034657 JD034670 HD070610 HD070619 JD034517 JD034612 HD070769 HD070770 JD034567 JD034570 HD070964 HD070987 HD071087 JD034773 KD014335 HD070293 JD034312 JD034313 JD034314 JD034315 JD034318 JD034319 JD034320 JD034321 JD034322 JD034323 JD034324 JD034325 JD034326 HD070304 HD070305 HD070306 HD070411 HD070413 HD070454  HD070471 HD070473 KD014194 KD014196 KD014246 KD014248 KD014249 KD014250 HD069264 HD069679 HD069680 HD069681 HD069682 HD069683 HD069684 HD069685 HD069686 HD069687 HD069688 HD069689 HD069690 HD069691 HD069692 HD069693 HD069694 HD069695 HD069696 HD069697 HD069698 HD069699 HD069700 HD069701 HD069702 HD069703 HD069704 HD069705 HD069706 HD069707 HD069708 HD069712 HD069713 HD069715 HD069716 HD069717 HD069718 HD069719 HD069720 HD069721 HD069722 HD069723 HD069724 HD069725 HD069726 HD069727 HD069728 HD069729 HD069730 HD069731 HD069732 HD069733 HD069734 HD069735 HD069736 HD069737 HD069738 HD069739 HD069740 HD069741 HD069742 HD069744 HD069746 HD069749 HD069751 HD069752 HD069753 HD069754 HD069762 HD069763 HD069764 HD069765 HD069766 HD069767 HD069768 HD069769 HD069770 HD069771 HD069772 HD069773 HD069774 HD069775 HD069776 HD069777 HD069791 KD014185 KD014206 KD014282 KD014283 KD014284 KD014290 KD014291 KD014292 KD014293 KD014303 KD014306 KD014308 KD014315 KD014333 KD014334 HD066549 HD066566 HD070332 HD070334 HD070336 HD070345 HD070347 HD070364 HD070366 HD070367 HD070814 HD070816 HD070900 HD070901 HD070912 HD070913 HD069918 HD069920 HD069923 HD069901 JD034201 JD034205 JD034216 JD034220 JD034222 HD070161 HD070163 HD070164 HD070173 HD070175 HD070343 HD070342 JD034339 JD034341 JD034342 JD034347 JD034348 JD034351 JD034336 JD034338 JD034352 JD034353 JD034354 JD034362 JD034366 JD034367 JD034556 JD034557 JD034558 JD034559 JD034572 JD034574 HD071279 HD071280 JD034344 JD034357 JD034365 JD034368 JD034370 JD034371 JD034372 JD034397 JD034403 JD034404 HD070495 HD070497 HD070498 HD070535 HD070537 HD070538 HD070547 HD070553 HD070561 HD070562 HD070716 HD070721 HD070723 HD070725 HD070726 HD070727 HD070729 HD070730 HD070732 HD070735 HD070737 HD070739 HD070740 HD070745 HD070746 HD070747 HD070748 HD070786 HD070789 HD070795 HD070486 HD070492 HD070536 HD070546 HD070566 HD070266 HD070275 HD070276 HD070278 HD070280 HD070281 HD070291 HD070292 HD070302 HD070303 HD070472 HD070475 HD070477 HD070480 KD014190 KD014214 KD014239 KD014314 HD070200 HD070201 HD070213 JD034195 HD070810 HD070820 HD070821 HD070822 HD070824 HD070898 HD070903 HD070904 HD070907 HD070908 HD070910 HD070911 HD070914 HD070918 HD070920 HD070921 HD070935 HD070937 HD070939 HD070943 HD069940 HD069968 HD069982 JD034157 JD034184 JD034191 JD034194 JD034199 JD034204 JD034503 JD034505 JD034516 JD034520 JD034580 JD034600 KD014122 KD014340 HD070284 HD070731 HD070917 JD034583 JD034585 JD034590 JD034593 JD034594 JD034595 HD070576 HD070580 JD034561 JD034562 JD034563 JD034564 JD034573 JD034575 JD034579 JD034596 JD034606 HD070589 HD070596 HD070353 HD070358 HD070621 JD034501 JD034518 HD070216 HD070221 HD070258 HD070259 HD070269 HD070282 HD070285 HD070299 HD070272 HD070835 KD014118 JD034170 HD070481 HD070601 HD070289 HD070294 HD070295 HD070296 HD070297 HD070307 HD070308 HD070309 HD070310 HD070479 KD014159 KD014330 KD014332 HD070862 HD070863 HD070877 HD070880 HD070882 HD070888 HD070846 HD070847 HD071101 HD071116 HD070734 HD070750 HD070753 MD003247 HD070261 HD070202 HD070594 HD070508 HD070742 HD070762 HD070772 HD070751 KD014309 HD070253 HD070254 HD070796 HD070798 HD070192 HD070194 HD070195 HD070203 HD070209 HD070218 HD070220 HD070251 HD070252 HD070255 HD070165 HD070166 HD070168 HD070193 HD070210 HD070841 HD070857 KD014278 KD014279 KD014281 HD070967 HD070979 HD070980 HD070984 HD070991 HD070992 HD071027 HD071060 HD071074 HD071075 HD071076 HD071077 HD071078 HD071079 HD071080 HD071081 HD071082 HD071083 HD071085 HD071086 HD071088 HD071089 HD071090 HD071091 HD071092 HD071093 HD071094 HD071095 HD071096 HD071110 HD070887 HD070892 HD070893 HD070894 HD070895 HD070896 HD070897 HD070899 HD070902 HD070905 HD070923 HD070924 HD070925 HD070926 HD070927 HD070928 HD070931 HD070932 HD070933 HD070934 HD070936 HD070938 HD070940 HD070941 HD070942 HD070944 HD070945 HD070946 HD071097 HD071099 HD070539 HD069944 HD069964 HD069965 HD070224 HD070229 HD070231 HD070234 HD070237 HD070240 HD070241 HD070244 HD070247 HD070511 HD070513 HD070514 HD070515 HD070517 HD070518 HD070519 KD014199 KD014202 KD014217 KD014222 KD014227 KD014228 KD014242 KD014243 HD070520 HD070521 HD070522 HD070523 HD070524 HD070526 HD070528 HD070529 JD034406 HD071272 MD003238 MD003239 MD003240 MD003248 MD003252 MD003253 MD003254 MD003257 MD003258 MD003262 JD034665 HD070381 HD070453 HD070464 HD070467 HD070398 HD070402 HD070404 HD070321 HD070337 HD070351 HD070484 HD070490 KD014224 HD070340 JD034416 JD034417 JD034420 JD034421 JD034426 JD034427 JD034428 JD034429 JD034430 JD034432 JD034435 JD034436 JD034438 JD034440 JD034449 HD069745 HD069748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33272 HS133273 HS133274 HS133275 HS133276 HS133277 HS133278 HS133279 HS133280 JS014808 JS014809 JS014816 JS014817 JS014855 JS014857 JS014858 JS014859 JS014860 JS014861 JS014862 JS014863 JS014864 JS014865 JS014866 JS014867 JS014868 JS014871 JS014873 JS014874 JS014875 JS014876 JS014877 JS014878 JS014879 JS014880 JS014881 JS014882 JS014883 JS014884 JS014885 JS014886 JS014887 JS014902 JS014903 KD014257 KD014267 KD014294 KD014295 KD014296 KD014297 KD014304 KD014305 KD014311 KD014313 ID039102 ID039103 ID039108 ID039110 ID039113 ID039115 ID039117 ID039120 ID039121 ID039122 ID039123 ID039124 ID039128 ID039132 ID039133 ID039135 ID039138 ID039139 ID039140 ID039145 ID039146 ID039147 ID039148 ID039151 ID039154 ID039155 ID039156 ID039160 ID039162 ID039164 ID039165 ID039169 ID039170 ID039171 ID039172 ID039175 ID039177 ID039178 ID039180 JD034502 JD034510 JD034511 JD034513 JD034514 JD034515 JD034607 JD034608 JD034736 JD034737 JD034738 JD034739 JD034740 JD034741 JD034743 JD034746 JD034759 JD034760 JD034765 JD034766 HD070491 HD070494 HD070496 HD070499 HD070501 HD070504 HD070525 HD070530 HD070531 HD070532 HD070541 HD070542 HD070543 HD070544 HD070549 HD070550 HD070551 HD070552 HD070555 HD070558 HD070559 HD070560 HD070564 HD070485 HD070487 HD070488 HD070489 HD070565 HD070567 HD070568
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of Colombia, Honduras, Iran, Thailand and Uruguay.
  • Descripción del producto
    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


  • Dirección del fabricante
    DeVilbiss Healthcare LLC, 100 Devilbiss Dr, Somerset PA 15501-2125
  • Empresa matriz del fabricante (2017)
  • Source