FDA Device recall Z-0019-2015
ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg)
- FDA Device
- Class II
- terminated
- Published 2014-10-15
On 2014-10-15 the FDA classified a Class II recall of ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg) by Arjo Hospital Equipment Ab, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0019-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-03-17 |
| Published | 2014-10-15 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Arjo Hospital Equipment Ab |
| Distribution | US |
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.
Reason
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.
Identifiers
| code_info | 1) Model Number: C1000; Serial Numbers (Foreign): 62265 , 399945 , 399946 , 399949 , 416912 , 416914 , 423215 ,…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 , 8 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0019-2015%22
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