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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67029

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 17, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Arjo Hospital Equipment AB

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-0019-2015
Recall number
Z-0019-2015
Initiated
March 17, 2014
Classification
Class II
Status
Terminated
Quantity
1,695 beds (worldwide)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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

Distribution pattern

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