Events

Retiro De Equipo (Recall) de Device Recall Contoura

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 Arjo Hospital Equipment AB.

¿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
    Recall
  • ID del evento
    67029
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0019-2015
  • Fecha de inicio del evento
    2014-03-17
  • Fecha de publicación del evento
    2014-10-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-02-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124572
  • 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
    Bed, ac-powered adjustable hospital - Product Code FNL
  • Causa
    There is a low but existing entrapment risk for a patient being treated on the contoura 1000 and contoura 1080 bariatric beds if they have a bmi < 40.
  • Acción
    ArjoHuntleigh sent an URGENT FIELD SAFETY NOTICE - IMMEDIATE ATTENTION REQUIRED letters dated March 17, 2014 to all affected cusomers. The letters included instructions for customers to: 1) ensure that the Contoura Bed Field Safety Notice brought to the attention of all caregivers and clinical staff and they are aware that the Contoura 1000 or 1080 medical bed is intended to be used as a bariatric medical bed, designed for the patients with BMI greater than 40; 2) ensure that all users of the Contoura 1000/1080 bed, applicable staff and caregivers are trained to ensure awareness of the revised Instructions for Use Manual and new bed label; 3) discard all previous versions of Contoura 1000/1080 Bed Instructions for Use Manuals and ensure that a copy of this Contoura Bed Field Safety Notice is placed in the enclosed revised Contoura 1000/1080 bed Instructions for Use Manual (746-173-AM-3 - 10/2013); 4) where applicable, include this requirement in subsequent training of applicable staff and caregivers; and, 5) complete and sign the enclosed Customer Response Form and return this form to the ArjoHuntleigh Regulatory Department. An ArjoHuntleigh Service Technician will contact the designated facility representative listed on the Customer Response Form to schedule service to apply the two labels shown above, free of charge. For question contact ArjoHuntleigh at 1-800-323-1245, ext. 57985.

Device

Device Recall Contoura
  • Modelo / Serial
    1) Model Number: C1000; Serial Numbers (Foreign): 62265 , 399945 , 399946 , 399949 , 416912 , 416914 , 423215 , 475309 , 530882 , 554079 , 554082 , 566463 , 584837 , 586554 , 592203 , 592204 , 592205 , 592206 , 597027 , 597028 , 605859 , 646152 , 664632 , 680670 , 680699 , 693924 , 695671 , 699563 , 712231 , 714227 , 714228 , 714229 , 716809 , 720277 , 725622 , 731631 , 745781 , 745782 , 747354 , 747355 , 748161 , 748162 , 748635 , 761635 , 766430 , 766430 , 766431 , 766431 , 771194 , 771195 , 771197 , 771198 , 798571 , 816742 , 821563 , 821564 , 821704 , 821705 , 821706 , 821707 , 822714 , 823713 , 823713 , 823714 , 832524 , 832525 , 832526 , 832527 , 832528 , 840918 , 840919 , 840919 , 840920 , 840920 , 840922 , 840923 , 840924 , 840925 , 840947 , 840948 , 840949 , 840950 , 847439 , 853387 , 855259 , 855260 , 855261 , 855262 , 871837 , 871840 , 871841 , 871842 , 871843 , 872720 , 873306 , 873307 , 873307 , 881203 , 881204 , 881205 , 881206 , 881207 , 889938 , 889939 , 901232 , 901233 , 901234 , 901236 , 901237 , 901244 , 904448 , 904449 , 904449. , 913969 , 916105 , 916108 , 924589 , 925887 , 929764 , 929772 , 945149 , 945151 , 945154 , 945160 , 8401918 , 648568Z1894 , 648569Z1894 , C1000 , M/M-1 , M/M-10 , M/M-2 , M/M-3 , M/M-4 , M/M-5 , M/M-6 , M/M-7 , M/M-8 , M/M-9 , P0100097 , P0100172 , P0100337 , P0100523 , P0100655 , P0100723 , P0101916 , P0101927 , P0101928 , P0101929 , P0101930 , P0101931 , P0102404 , P0102894 , P0102895 , P0102896 , P0102897 , P0102898 , P0103581 , P0103582 , P0103583 , P0106046 , P0106705 , P0106707 , P0108275 , P0108276 , P0109784 , P0110620 , P0111754 , P0114163 , P0114164 , P0115132 , P0118357 , P0118358 , P0120283 , P0120855 , P0120862 , P0121025 , P0121307 , P0121308 , P0121605 , P0121857 , P0122187 , P0122459 , P0125170 , P0126006 , P0126089 , P0126317 , P0126318 , P0126326 , P0126865 , P0126866 , P0126867 , P0128593 , P0128594 , P0130033 , P0132561 , P0133271 , P0133392 , P0133482 , P013391 , P0134514 , P0137082¿¿¿ , P0137164 , P0137540 , P0138061 , P0138062 , P0138242 , P0138520 , P0138710 , P0138780 , P0138781 , P0139072 , P0143580¿¿¿ , P0143581¿¿¿ , P0143714 , P0144844¿¿¿ , P0144845¿¿¿ , P0145951 , P0146630 , P0146631 , P0146632 , P0147602 , P0147657 , P0147790 , P0147791 , P0147792 , P0148713 , P015878 , P015879 , P015880 , P015881 , P015882 , P015883 , P015884 , P015885 , P015886 , P015887 , P015888 , P015889 , P015890 , P015891 , P015892 , P015893 , P015894 , P015895 , P015896 , P015897 , P016101 , P016102 , P0162202 , P0162203 , P0162204 , P0162368 , P0162369 , P0163463 , P016386 , P016387 , P016388 , P016389 , P016392 , P016394 , P0164651¿¿¿ , P0164652¿¿¿ , P0164972 , P0167357 , P0167465 , P0167466 , P0168015 , P0170588 , P0170689 , P0170690 , P0170968¿¿¿ , P0170969¿¿¿ , P0170981 , P0170982 , P0171406 , P0171918 , P0175182 , P0175368 , P0175369 , P0175370 , P0175545 , P0175546 , P0176591 , P0177062 , P0177063 , P017742 , P0178144 , P0178145 , P0178146 , P0178147 , P0178884 , P0178994 , P0179154 , P0180855 , P0180856 , P0180857 , P0180858 , P0181259 , P0181260 , P0182476¿¿¿ , P0183725 , P0183726 , P0183727 , P0183728 , P0183729 , P0183730 , P0183731 , P0183732 , P0184221 , P0184222 , P0185060 , P0185078 , P0185233 , P0185307 , P0185896 , P0189314 , P0189315 , P0189316 , P019458 , P019459 , P019460 , P019461 , P021789 , P021791 , P021888 , P021894 , P022021 , P022022 , P022023 , P022759 , P022760 , P022761 , P023170 , P025354 , P025355 , P025968 , P025969 , P026033 , P026034 , P026125 , P026126 , P026302 , P026303 , P027324 , P027461 , P027954 , P027956 , P029384 , P031686 , P031774 , P032359 , P032387 , P034422 , P034423 , P034732 , P035210 , P035600 , P035705 , P036000 , P037150 , P038617 , P038752 , P038753 , P038894 , P039590 , P040635 , P040812 , P041044 , P041473 , P041617 , P042386 , P042430 , P042473 , P042474 , P042595 , P042596 , P042657 , P042727 , P042728 , P042842 , P043140 , P043232 , P043521 , P045035 , P045367 , P046255 , P046256 , P047337 , P047480 , P049467 , P049468 , P050432 , P050489 , P052233 , P056073 , P056861 , P056862 , P058743 , P060073 , P060179 , P060529 , P060857 , P060858 , P060918 , P060919 , P060920 , P062505 , P062609 , P062847 , P063301 , P063853 , P064395 , P064483 , P064500 , P064575¿¿¿¿ , P064719¿¿¿¿ , P064815 , P064816 , P065140 , P065141 , P065193 , P065314 , P065400 , P065401 , P066218 , P066570 , P066615 , P067019 , P067086 , P067087 , P067393 , P067441 , P067482 , P068002 , P068266 , P068700 , P068988 , P070081 , P070435 , P070443 , P070713 , P070770 , P071349 , P071350 , P071451 , P073778 , P073847 , P073934 , P075170 , P076716 , P076719 , P076849 , P076950 , P078419 , P079322 , P079323 , P080384 , P083938 , P084481 , P084594 , P085062 , P086507 , P086508 , P086830 , P086831 , P087584¿¿¿¿ , P087585 , P087853 , P088197 , P088210 , P088272 , P088570 , P088655 , P092355 , P093705 , P093834 , P094960 , P094961 , P096673 , P096674 , P096675 , P097132 , P097311 , P097500 , P099166 , P099167 , P099444 , P099445 , P099721 , P100052 , P100053 , PO106703 , PO106704 , PO106706 , PO29057 , PO29058 , PO29059 , PO84691 , PO84692 , PO84693 , PO84694 , PO84695 , PO84696 , PO84697 , PO84698 ;   1) Model Number C1080; Serial Numbers (US): 416930 , 766425 , 473239 , 773201 , 851902 , 416917 , 491904 , 545574 , 473246 , 416932 , 473245 , 473238 , 82730 , 783942 , 416919 , 473243 , 545569 , 473234 , 416920 , 416926 , 473236 , 830902 , 416927 , 491906 , 416931 , 416921 , 491895 , 745779 , 561704 , 561689 , 766423 , 416922 , 774737 , 416925 , 416928 , 491908 , 473242 , 491900 , 822726 , 836910 , 545567 , 473233 , 561700 , 491903 , 836902 , 82996 , 473240 , 745778 , 747442 , 561691 , 561695 , 561701 , 491893 , 545579 , 725635 , 304528 , 304527 , 747444 , 745780 , 473241 , 545573 , 816751 , 816748 , 812748 , 836904 , 304530 , 491896 , 545580 , 545570 , 545568 , 561693 , 774730 , 473232 , 491901 , 725633 , 561699;  Serial Numbers (Foreign): 18045 , 18151 , 18152 , 18153 , 18154 , 18155 , 18366 , 93080 , 114143 , 276987 , 366998 , 378830 , 378831 , 386998 , 398332 , 398333 , 442500 , 442501 , 442502 , 475308 , 479362 , 479363 , 479364 , 479365 , 479367 , 493548 , 493549 , 493550 , 493551 , 493552 , 493553 , 493554 , 493555 , 493556 , 493557 , 511571 , 511572 , 511573 , 566464 , 566465 , 602665 , 684642 , 695358 , 701859 , 701948 , 725623 , 725624 , 725625 , 725626 , 725627 , 725629 , 725631 , 745783 , 751632 , 765776 , 765777 , 778573 , 778575 , 778576 , 778577 , 778578 , 822721 , 822721 , 822730 , 822730 , 822731 , 822732 , 830904 , 830905 , 831024 , 831025 , 840921 , 844771 , 848196 , 848199 , 848203 , 848206 , 848207 , 848931 , 857830 , 857831 , 871844 , 873308 , 873309 , 873310 , 873311 , 895437 , 895438 , 901247 , 901248 , 904455 , 905470 , 925888 , 925889 , 925890 , 925901 , 929765 , 929766 , 929769 , 934938 , 934939 , 935002 , 945140 , 945142 , 945143 , 945145 , 945146 , 945147 , C1080 , CO10800103 , CO10800104 , CO10800105 , CO10800106 , CO10800107 , D778574 , G/493557 , P0032040 , P0032041 , P0100336 , P0100409 , P0101003 , P0101329 , P0101330 , P0101331 , P0101332 , P0101333 , P0101510 , P0101511 , P0101512 , P0101513 , P0101514 , P0101515 , P0101516 , P0106045 , P0106415 , P0106416 , P0106417¿¿¿ , P0107780 , P0108277 , P0108715 , P0108716 , P0108717 , P0109782 , P0109783 , P0109954 , P0110233 , P0111026 , P0111276 , P0111872 , P0111873 , P0112155 , P0112156 , P0112157 , P0112158 , P0112955 , P0113151 , P0113364 , P0115133 , P0115301 , P0115302 , P0116051 , P0116614 , P0116615 , P0117468 , P0117880 , P0117881 , P0122188 , P0122460 , P0125766 , P0125767 , P0127623 , P0127849 , P0128225 , P0128420 , P0128875 , P0129052 , P0129155 , P0129451 , P0129572 , P0130354 , P0132046 , P0132726 , P0133301 , P0133777 , P0133835 , P0133836 , P0133837 , P0134515 , P0135473 , P0138875 , P0149304 , P0149305 , P0160131 , P0163554 , P0164049 , P0164216 , P0164438 , P0164532 , P0165078 , P0165079 , P0165080 , P0165081 , P0166465 , P0166466 , P0166834 , P0167425 , P0167651 , P0167682 , P0169577 , P0170398 , P0170970¿¿¿ , P0172128 , P0172129 , P0172423 , P0172424 , P0172425 , P0172426 , P0172623 , P0172718 , P0175806 , P0175807 , P0177061 , P0178143 , P0181261 , P0183905 , P0186868 , P0186870 , P0188652 , P018869 , P0189663 , P0189664 , P019147 , P019148 , P019149 , P019150 , P019151 , P019275 , P019276 , P019277 , P019283 , P019322 , P019323 , P019326 , P019327 , P019801 , P019802 , P019803 , P019804 , P020452 , P020453 , P021332 , P021333 , P021792 , P021794 , P022018 , P022019 , P023898 , P023901 , P024623 , P025150 , P025151 , P026436 , P026437 , P026438 , P026439 , P026440 , P026619 , P026620 , P026621 , P026804 , P027081 , P027082 , P027321 , P027322 , P027323 , P027744 , P027953 , P028299 , P030415 , P030416 , P030863 , P030864 , P031143 , P031144 , P031530 , P034344 , P034345 , P034346 , P034424 , P034425 , P034542 , P034611 , P035841 , P035976 , P035977 , P036591 , P039475 , P039476 , P039591 , P039749 , P041222 , P041223 , P041615 , P041616 , P041932 , P041972 , P041973 , P041974 , P042167 , P042282 , P042284 , P042285 , P048169 , P048170 , P050022 , P050433 , P051327¿¿¿¿ , P051626 , P053704 , P054140 , P054376 , P054593 , P056636 , P056860 , P058001 , P058621 , P058622 , P059546¿¿¿¿ , P059634¿¿¿¿ , P059635¿¿¿¿ , P060675 , P060676 , P062509 , P062978 , P064317 , P065625 , P065806 , P066048 , P067245 , P067504 , P068235 , P068236 , P069079 , P069178 , P069334 , P069335 , P069615 , P070949 , P071725 , P073528 , P075036 , P075802 , P075946 , P076331 , P076526 , P079075 , P079321 , P081497 , P081583 , P081584 , P081854 , P082674 , P083243 , P083666 , P084374 , P086826 , P087950 , P088488 , P094207 , P094411 , P096286 , P097604 , P0M6050 , PO137838 , PO146396 , PO190805 , PO19275 , PO47568 , R61213
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US: Nationwide in the states of (AZ, CA, CO, CT, GA, ID, IL, MA, MD, MN, NC, NE, OH, PA, RI, SD, TX, VA, WI); and the countries of Australia, Austria, Bahrain, Belgium, Canada, Denmark, France, Germany, Greece, Iceland, India, Ireland, Israel, Italy, Lebanon, Mexico, Netherlands, New Zealand, Norway, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, United Arab Emirates
  • Descripción del producto
    ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1000 is the basic bed. Model C1080 includes a weighing system and a power outlet for an ArjoHuntleigh approved mattress pump. || Product Usage: || The Contoura series bariatric beds are electrically operating medical beds with a maximum patient weight of 450 kg. This range is intended for use in hospitals to facilitate management of obese patients. An optional integrated weighing system helps with assessment and management of the patient if required.
  • Manufacturer
    Arjo Hospital Equipment AB

Manufacturer

Arjo Hospital Equipment AB
  • Dirección del fabricante
    Arjo Hospital Equipment AB, Verkstadsvagen 5, Eslov Sweden
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    USFDA