FDAFDA · Food and drugs·Recall number Z-2652-2014
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).
Published September 24, 2014 · Recall initiated: June 10, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- ARJOHUNTLEIGH POLSKA SP. ZO.O.
- Distributor
- 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.
- Lot
- 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 ,
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Poland
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