Events

Retiro De Equipo (Recall) de Device Recall Tenor

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por ARJOHUNTLEIGH POLSKA SP. ZO.O..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    68113
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2652-2014
  • Fecha de inicio del evento
    2014-06-10
  • Fecha de publicación del evento
    2014-09-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-06-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126956
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Lift, patient, non-ac-powered - Product Code FSA
  • Causa
    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.
  • Acción
    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
  • Modelo / 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
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    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.
  • Dirección del fabricante
    ARJOHUNTLEIGH POLSKA SP. ZO.O., UI. KS. WAWRZYNIAKA 2, KOMORNIKI, POZNAN Poland
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    USFDA