CLASS II Device recall · Reported 24 Sep 2014 · FDA Enforcement Report

Tenor is a mobile passive lift recalled by Arjohuntleigh Polska Sp. Zo.o

Arjohuntleigh Polska SP. ZO.O is recalling Tenor is a mobile passive lift, intended to be used on horizontal surfaces for lifting, distributed nationwide in the US. The recall was initiated on 10 Jun 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number: KHA1000-US; Serial Numbers: P0111930 , P0112213 , P0112214 , P0117472 , P0121496 , P0123586 , P0125147 , P0127106 , P0127347 , P0127348 , P0128923 , P0128924 , P0129153 , P0129154 , P0129369 , P0129370 , P0131041 , P0131526 , P0131527 , P0131773 , P0131774 , P0133024 , P0134145 , P0134146 , P0136335 , P0137220 , P0138564 , P0139494 , P0139495 , P0139696 , P0144387 , P0148499 , P0149211 , P0149302 , P0149303 , P0162196 , P0164314 , P0165868 , P0165941 , P0166383 , P0166464 , P0167748 , P0170439 , P0172605 , P0172717 , P0179187 , P0179414 , P0180046 , P0180047 , P0180480 , P0180481 , P0180482 , P0180483 , P0183127 , P0183128 , P0183764 , P0183765 , P0183824 , P0184254 , P0186224 , P0186225 , P0187652 , P0187653 , P0188944 , P0189050 , P0189099 , P0189762 , P0192050 , P0192249 , P0208300 , P0209851 , P0210756 , P0210792 , P0210793 , P0211855 , P0211856 , P0211980 , P0211981 , P0212717 , P0217417 , P0218714 , P0220790 , P0221243 , P0221244 , TCMA0405021 , TCMNS0404E154 , TCMNS0404E155 , TCMNS0404U044 , TCMNS0404U045 , TCMNS0408E159 , TCMNS0408E160 , TCMNS0408E161 , TCMNS0409E163 , TCMNS0409G144 , TCMNS0409G145 , TCMNS0409G146 , TCMNS0409G147 , TCMNS0409U046 , TCMNS0409U047 , TCMNS0409U048 , TCMNS0409U049 , TCMNS0409U050 , TCMNS0409U051 , TCMNS0409U052 , TCMNS0409U053 , TCMNS0410G164 , TCMNS0410G165 , TCMNS0410G166 , TCMNS0410G167 , TCMNS0410G168 , TCMNS0410G169 , TCMNS0411E170 , TCMNS0412E228 , TCMNS0412E229 , TCMNS0412G171 , TCMNS0412G172 , TCMNS0412G173 , TCMNS0501G233 , TCMNS0501G234 , TCMNS0501G235 , TCMNS0501U264 , TCMNS0501U265 , TCMNS0501U274 , TCMNS0501U275 , TCMNS0501U276 , TCMNS0502A279 , TCMNS0502E288 , TCMNS0502G266 , TCMNS0502G267 , TCMNS0502G268 , TCMNS0502G269 , TCMNS0502G270 , TCMNS0502G271 , TCMNS0502U320 , TCMNS0502U321 , TCMNS0504U328 , TCMNS0504U329 , TCMNS0504U330 , TCMNS0505E333 , TCMNS0506E350 , TCMNS0507A396 , TCMNS0507A397 , TCMNS0507A398 , TCMNS0508E400 , TCMNS0508E401 , TCMNS0508E402 , TCMNS0508E403 , TCMNS0509U404 , TCMNS0509U405 , TCMNS0510E408 , TCMNS0510U407 , TCMNS0511E410 , TCMNS0511E419 , TCMNS0511E422 , TCMNS0511U409 , TCMNS0511U417 , TCMNS0511U418 , TCMNS0601E454 , TCMNS0602E470 , TCMNS0602E471 , TCMNS0602G472 , TCMNS0602G473 , TCMNS0603U564 , TCMNS0603U565 , TCMNS0603U566 , TCMNS0604G640 , TCMNS0605E641 , TCMNS0606G643 , TCMNS0606G644 , TCMNS0607A664 , TCMNS0607A665 , TCMNS0607A666 , TCMNS0607E658 , TCMNS0607G650 , TCMNS0607G651 , TCMNS0607G656 , TCMNS0607G657 , TCMNS0608E667 , TCMNS0608U669 , TCMNS0608U670 , TCMNS0608U671 , TCMNS0608U699 , TCMNS0608U700 , TCMNS0608U701 , TCMNS0609U702 , TCMNS0609U703 , TCMNS0609U704 , TCMNS0610E736 , TCMNS0610E737 , TCMNS0610E738 , TCMNS0610U708 , TCMNS0610U709 , TCMNS0610U734 , TCMNS0610U735 , TCMNS0612E755 , TCMNS0612U756 , TCMNS0612U757 , TCMNS0701E771 , TCMNS0701E772 , TCMNS0701U774 , TCMNS0703E792 , TCMNS0703E793 , TCMNS0704U824 , TCMNS0704U825 , TCMNS0704U826 , TCMNS0705E828 , TCMNS0705E829 , TCMNS0705G827 , TCMNS0706A868 , TCMNS0706A869 , TCMNS0706G865 , TCMNS0706G866 , TCMNS0706U832 , TCMNS0706U847 , TCMNS0707E888 , TCMNS0707E890 , TCMNS0707E892 , TCMNS0707G889 , TCMNS0707U872 , TCMNS0707U873 , TCMNS0707U891 , TCMNS0708U894 , TCMNS0709U909 , TCMNS0709U910 , TCMNS0709U911 , TCMNS0710E925 , TCMNS0710U940 , TCMNS0710U955 , TCMNS0711E958 , TCMNS0802E020 , TCMNS0802E028 , TCMNS0802E029 , TCMNS0803E056 , TCMNS0803U057 , TCMNS0803U058 , TCMNS0804E072 , TCMNS0804U075 , TCMNS0805A076 , TCMNS0805A077 , TCMNS0805A078 , TCMNS0805A079 , TCMNS0805A080 , TCMNS0805A081 , TCMNS0805A082 , TCMNS0805A083 , TCMNS0805A084 , TCMNS0805A085 , TCMNS0805U093 , TCMNS0805U094 , TCMNS0806G120 , TCMNS0806G121 , TCMNS0806G122 , TCMNS0806G123 , TCMNS0806G124 , TCMNS0807A143 , TCMNS0808E160 , TCMNS0808E163 , TCMNS0808U161 , TCMNS0808U162 , TCMNS0808U165 , TCMNS0808U166 , TCMNS0808U167 , TCMNS0808U168 , TCMNS0809E169 , TCMNS0809E171 , TCMNS0809U170 , TCMNS0810E188 , TCMNS0810E205 , TCMNS0810E206 , TCMNS0810E207 , TCMNS0810E209 , TCMNS0810U190 , TCMNS0810U191 , TCMNS0810U192 , TCMNS0810U193 , TCMNS0811E225 , TCMNS0811E226 , TCMNS0811E227 , TCMNS0811E228 , TCMNS0901E232 , TCMNS0901E271 , TCMNS0901U266 , TCMNS0901U267 , TCMNS0901U268 , TCMNS0901U269 , TCMNS0902G313 , TCMNS0902G314 , TCMNS0902U296 , TCMNS0902U302 , TCMNS0903G318 , TCMNS0903G319 , TCMNS0904E321 , TCMNS0904G322 , TCMNS0904U338 , TCMNS0904U339 , TCMNS0904U367 , TCMNS0904U368 , TCMNS0904U369 , TCMNS0905G372 , TCMNS0905G373 , TCMNS0905G374 , TCMNS0905G375 , TCMNS0905G376 , TCMNS0905G377 , TCMNS0905U370 , TCMNS0905U389 , TCMNS0905U390 , TCMNS0905U391 , TCMNS0905U392 , TCMNS0907U411 , TCMNS0907U412 , TCMNS0907U413 , TCMNS0907U414 , TCMNS0908E441 , TCMNS0908U426 , TCMNS0908U427 , TCMNS0908U428 , TCMNS0908U429 , TCMNS0910U445 , TCMNS0910U446 , TCMNS0910U447 , TCMNS0910U448 , TCMNS0910U449 , TCMNS0910U450 , TCMNS0910U451 , TCMNS0910U452 , TN0911E003 , TN0911E004 , TN0911E005 , TN1002G006 , TN1004U007 , TN1004U008 , TN1005E011 , TN1005U009 , TN1005U010 , TN1006U012 , TN1006U013 , TN1009E016 , TN1009U014 , TN1009U015 , TN1009U017 , TN1010U018 , TN1010U019 , TN1010U020 , TN1010U021 , TN1012E023 , TN1012U022 , TN1102E001 , TN1102E002 , TN1103G003 , TN1103G004 , TN1103G005 , TN1103G006 , TN1103G007 , TN1103G008 , TN1103G009 , TN1104E016 , TN1104E017 , TN1104E018 , TN1104U010 , TN1104U011 , TN1104U012 , TN1104U013 , TN1104U014 , TN1104U015 , TN1105E021 , TN1105U019 , TN1105U020 , TN1106E022 , TN1106E023 , TN1106E024 , TN1106U025 , TN1106U026 , TN1106U027 , TN1106U028 , TN1106U029 , TN1107E030 , TN1107E031 , TN1107E032 , TS0911E001 , TS0911E002 , TS1108A033

Quantity recalled382 lifts total worldwide (160 US)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2652-2014
FDA event ID: 68113
Recalling firm: Arjohuntleigh Polska SP. ZO.O, POZNAN, N/A
Classification: Class II
Status: Terminated
Recall initiated: 10 Jun 2014
FDA classified: 16 Sep 2014
Reported: 24 Sep 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Wheelchairs, Beds & Lifts

Timeline

10 Jun 2014	Recall initiated by company
16 Sep 2014	Classified by FDA	+98 days
24 Sep 2014	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

ArjoHuntleigh received reports where the Tenor Lift without Scale (spreader bar) bolt broke during use. There is a remote risk concerning the breakage of the spreader bar bolt connection, part # TEN.018. During use, the bolt is subjected to mechanical forces, which may lead to breakage.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Tenor is a mobile passive lift, intended to be used on horizontal surfaces for lifting and transfer in hospitals, nursing homes or other healthcare facilities. Transfers with the Tenor are made indoors in the patient's room, in communal areas or in a bathroom. Tenor is meant to be used with the patient type who: sits in a wheelchair, has no capability to support themselves at all, cannot stand unsupported and is not able to bear weight (not even partially), is dependent on caregiver in most situations, is a passive resident, might be almost completely bed ridden, is often stiff and has contracted joints, and/or is totally dependent. The Tenor has a safe working load of 320 KG (705 lbs).

Where it was distributed

Worldwide Distribution - USA (nationwide) and Internationally to Australia, Bahrain, Canada, France, Germany, India, Ireland, Israel, Italy, Mexico, Netherlands, New Zealand, Poland, Romania, Saudi Arabia, South Africa, Spain, Sweden, United Kingdom, and Uruguay.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Model Number: KHA1000-US; Serial Numbers: P0111930 , P0112213 , P0112214 , P0117472 , P0121496 , P0123586 , P0125147 , P0127106 , P0127347 , P0127348 , P0128923 , P0128924 , P0129153 , P0129154 , P0129369 , P0129370 , P0131041 , P0131526 , P0131527 , P0131773 , P0131774 , P0133024 , P0134145 , P0134146 , P0136335 , P0137220 , P0138564 , P0139494 , P0139495 , P0139696 , P0144387 , P0148499 , P0149211 , P0149302 , P0149303 , P0162196 , P0164314 , P0165868 , P0165941 , P0166383 , P0166464 , P0167748 , P0170439 , P0172605 , P0172717 , P0179187 , P0179414 , P0180046 , P0180047 , P0180480 , P0180481 , P0180482 , P0180483 , P0183127 , P0183128 , P0183764 , P0183765 , P0183824 , P0184254 , P0186224 , P0186225 , P0187652 , P0187653 , P0188944 , P0189050 , P0189099 , P0189762 , P0192050 , P0192249 , P0208300 , P0209851 , P0210756 , P0210792 , P0210793 , P0211855 , P0211856 , P0211980 , P0211981 , P0212717 , P0217417 , P0218714 , P0220790 , P0221243 , P0221244 , TCMA0405021 , TCMNS0404E154 , TCMNS0404E155 , TCMNS0404U044 , TCMNS0404U045 , TCMNS0408E159 , TCMNS0408E160 , TCMNS0408E161 , TCMNS0409E163 , TCMNS0409G144 , TCMNS0409G145 , TCMNS0409G146 , TCMNS0409G147 , TCMNS0409U046 , TCMNS0409U047 , TCMNS0409U048 , TCMNS0409U049 , TCMNS0409U050 , TCMNS0409U051 , TCMNS0409U052 , TCMNS0409U053 , TCMNS0410G164 , TCMNS0410G165 , TCMNS0410G166 , TCMNS0410G167 , TCMNS0410G168 , TCMNS0410G169 , TCMNS0411E170 , TCMNS0412E228 , TCMNS0412E229 , TCMNS0412G171 , TCMNS0412G172 , TCMNS0412G173 , TCMNS0501G233 , TCMNS0501G234 , TCMNS0501G235 , TCMNS0501U264 , TCMNS0501U265 , TCMNS0501U274 , TCMNS0501U275 , TCMNS0501U276 , TCMNS0502A279 , TCMNS0502E288 , TCMNS0502G266 , TCMNS0502G267 , TCMNS0502G268 , TCMNS0502G269 , TCMNS0502G270 , TCMNS0502G271 , TCMNS0502U320 , TCMNS0502U321 , TCMNS0504U328 , TCMNS0504U329 , TCMNS0504U330 , TCMNS0505E333 , TCMNS0506E350 , TCMNS0507A396 , TCMNS0507A397 , TCMNS0507A398 , TCMNS0508E400 , TCMNS0508E401 , TCMNS0508E402 , TCMNS0508E403 , TCMNS0509U404 , TCMNS0509U405 , TCMNS0510E408 , TCMNS0510U407 , TCMNS0511E410 , TCMNS0511E419 , TCMNS0511E422 , TCMNS0511U409 , TCMNS0511U417 , TCMNS0511U418 , TCMNS0601E454 , TCMNS0602E470 , TCMNS0602E471 , TCMNS0602G472 , TCMNS0602G473 , TCMNS0603U564 , TCMNS0603U565 , TCMNS0603U566 , TCMNS0604G640 , TCMNS0605E641 , TCMNS0606G643 , TCMNS0606G644 , TCMNS0607A664 , TCMNS0607A665 , TCMNS0607A666 , TCMNS0607E658 , TCMNS0607G650 , TCMNS0607G651 , TCMNS0607G656 , TCMNS0607G657 , TCMNS0608E667 , TCMNS0608U669 , TCMNS0608U670 , TCMNS0608U671 , TCMNS0608U699 , TCMNS0608U700 , TCMNS0608U701 , TCMNS0609U702 , TCMNS0609U703 , TCMNS0609U704 , TCMNS0610E736 , TCMNS0610E737 , TCMNS0610E738 , TCMNS0610U708 , TCMNS0610U709 , TCMNS0610U734 , TCMNS0610U735 , TCMNS0612E755 , TCMNS0612U756 , TCMNS0612U757 , TCMNS0701E771 , TCMNS0701E772 , TCMNS0701U774 , TCMNS0703E792 , TCMNS0703E793 , TCMNS0704U824 , TCMNS0704U825 , TCMNS0704U826 , TCMNS0705E828 , TCMNS0705E829 , TCMNS0705G827 , TCMNS0706A868 , TCMNS0706A869 , TCMNS0706G865 , TCMNS0706G866 , TCMNS0706U832 , TCMNS0706U847 , TCMNS0707E888 , TCMNS0707E890 , TCMNS0707E892 , TCMNS0707G889 , TCMNS0707U872 , TCMNS0707U873 , TCMNS0707U891 , TCMNS0708U894 , TCMNS0709U909 , TCMNS0709U910 , TCMNS0709U911 , TCMNS0710E925 , TCMNS0710U940 , TCMNS0710U955 , TCMNS0711E958 , TCMNS0802E020 , TCMNS0802E028 , TCMNS0802E029 , TCMNS0803E056 , TCMNS0803U057 , TCMNS0803U058 , TCMNS0804E072 , TCMNS0804U075 , TCMNS0805A076 , TCMNS0805A077 , TCMNS0805A078 , TCMNS0805A079 , TCMNS0805A080 , TCMNS0805A081 , TCMNS0805A082 , TCMNS0805A083 , TCMNS0805A084 , TCMNS0805A085 , TCMNS0805U093 , TCMNS0805U094 , TCMNS0806G120 , TCMNS0806G121 , TCMNS0806G122 , TCMNS0806G123 , TCMNS0806G124 , TCMNS0807A143 , TCMNS0808E160 , TCMNS0808E163 , TCMNS0808U161 , TCMNS0808U162 , TCMNS0808U165 , TCMNS0808U166 , TCMNS0808U167 , TCMNS0808U168 , TCMNS0809E169 , TCMNS0809E171 , TCMNS0809U170 , TCMNS0810E188 , TCMNS0810E205 , TCMNS0810E206 , TCMNS0810E207 , TCMNS0810E209 , TCMNS0810U190 , TCMNS0810U191 , TCMNS0810U192 , TCMNS0810U193 , TCMNS0811E225 , TCMNS0811E226 , TCMNS0811E227 , TCMNS0811E228 , TCMNS0901E232 , TCMNS0901E271 , TCMNS0901U266 , TCMNS0901U267 , TCMNS0901U268 , TCMNS0901U269 , TCMNS0902G313 , TCMNS0902G314 , TCMNS0902U296 , TCMNS0902U302 , TCMNS0903G318 , TCMNS0903G319 , TCMNS0904E321 , TCMNS0904G322 , TCMNS0904U338 , TCMNS0904U339 , TCMNS0904U367 , TCMNS0904U368 , TCMNS0904U369 , TCMNS0905G372 , TCMNS0905G373 , TCMNS0905G374 , TCMNS0905G375 , TCMNS0905G376 , TCMNS0905G377 , TCMNS0905U370 , TCMNS0905U389 , TCMNS0905U390 , TCMNS0905U391 , TCMNS0905U392 , TCMNS0907U411 , TCMNS0907U412 , TCMNS0907U413 , TCMNS0907U414 , TCMNS0908E441 , TCMNS0908U426 , TCMNS0908U427 , TCMNS0908U428 , TCMNS0908U429 , TCMNS0910U445 , TCMNS0910U446 , TCMNS0910U447 , TCMNS0910U448 , TCMNS0910U449 , TCMNS0910U450 , TCMNS0910U451 , TCMNS0910U452 , TN0911E003 , TN0911E004 , TN0911E005 , TN1002G006 , TN1004U007 , TN1004U008 , TN1005E011 , TN1005U009 , TN1005U010 , TN1006U012 , TN1006U013 , TN1009E016 , TN1009U014 , TN1009U015 , TN1009U017 , TN1010U018 , TN1010U019 , TN1010U020 , TN1010U021 , TN1012E023 , TN1012U022 , TN1102E001 , TN1102E002 , TN1103G003 , TN1103G004 , TN1103G005 , TN1103G006 , TN1103G007 , TN1103G008 , TN1103G009 , TN1104E016 , TN1104E017 , TN1104E018 , TN1104U010 , TN1104U011 , TN1104U012 , TN1104U013 , TN1104U014 , TN1104U015 , TN1105E021 , TN1105U019 , TN1105U020 , TN1106E022 , TN1106E023 , TN1106E024 , TN1106U025 , TN1106U026 , TN1106U027 , TN1106U028 , TN1106U029 , TN1107E030 , TN1107E031 , TN1107E032 , TS0911E001 , TS0911E002 , TS1108A033

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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