Events

Device Recall Tenor 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 ARJOHUNTLEIGH POLSKA SP. ZO.O. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    68113
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2652-2014
  • 사례 시작날짜
    2014-06-10
  • 사례 출판 날짜
    2014-09-16
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-06-20
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126956
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    Lift, patient, non-ac-powered - Product Code FSA
  • 원인
    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.
  • 조치
    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
  • 모델명 / 제조번호(시리얼번호)
    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
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    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.
  • 제조사 주소
    ARJOHUNTLEIGH POLSKA SP. ZO.O., UI. KS. WAWRZYNIAKA 2, KOMORNIKI, POZNAN Poland
  • 제조사 모회사 (2017)
    Getinge AB
  • Source
    USFDA