Z-0019-2015Class II

ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450...

Name: Z-0019-2015 ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450...
Creator: Arjo Hospital Equipment AB
Published: 2014-03-17
License: https://open.fda.gov/license/

Arjohuntleigh AB / initiated 2014-03-17 / Terminated / root cause: labeling and UDI

FDA source

Arjo Hospital Equipment AB began a recall of 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... on 2014-03-17. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0019-2015
Classification: Class II
Status: Terminated
Initiated: 2014-03-17
Posted: 2014-10-06
Terminated: 2018-02-14
Recalling firm: Arjohuntleigh AB
Product: 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.
Product code: FNL Bed, Ac-Powered Adjustable Hospital
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: 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.
Quantity in commerce: 1,695 beds (worldwide)
Distribution: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0019-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0019-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-15	2014-10-06

Product code FNL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)