Events

Recall of Device Recall Tenor

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by ARJOHUNTLEIGH POLSKA SP. ZO.O..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    68113
  • Event Risk Class
    Class 2
  • Event Number
    Z-2652-2014
  • Event Initiated Date
    2014-06-10
  • Event Date Posted
    2014-09-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-06-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126956
  • Notes / Alerts
    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.
  • Extra notes in the data
    Lift, patient, non-ac-powered - Product Code FSA
  • Reason
    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.
  • Action
    ArjoHuntleigh sent an URGENT - FIELD SAFETY NOTICE letter dated June 10, 2014, to all affected customers. The letter included instructions for direct accounts to: 1) ensure that caregivers and users of the Tenor patient transfer lift referenced above are made aware of the field safety notice; 2) ensure that a copy of the field safety notice is placed in the Tenor Lift Instructions for Use manual for future reference and training; 3) complete and sign the enclosed Customer Response Form and return the form to the ArjoHuntleigh Regulatory Department; 4) and to be advised that an ArjoHuntleigh Service Technician will contact the facility representative listed on the Customer Response Form to schedule service to replace your spreader bar, free of charge. Customers with questions about this recall can contact ArjoHuntleigh at 800-323-1245 x 57985 or via e-mail at AHNA-RA@arjohuntleigh.com.

Device

Device Recall Tenor
  • Model / Serial
    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
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    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).
  • Manufacturer
    ARJOHUNTLEIGH POLSKA SP. ZO.O.

Manufacturer

ARJOHUNTLEIGH POLSKA SP. ZO.O.
  • Manufacturer Address
    ARJOHUNTLEIGH POLSKA SP. ZO.O., UI. KS. WAWRZYNIAKA 2, KOMORNIKI, POZNAN Poland
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    USFDA