Events

Sechrist 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Sechrist Industries Inc 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
    45906
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0733-2008
  • 사례 시작날짜
    2007-10-31
  • 사례 출판 날짜
    2008-01-18
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-04-19
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66457
  • 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
    Stretcher - Product Code FPO
  • 원인
    Brake problems: the stretcher brake cams may crack while attempting to lock the stretcher brake (sechrist is supplied the stretchers by the manufacturer stryker medical).
  • 조치
    Urgent Medical Device Correction letters were sent to customers beginning on November 9, 2007, via FedEx & DHL overnight. Customers were notified this action was being taken to providing notification to their customers as a continued implementation of the Stryker Medical field correction. The Notification letter instructed their customers to: 1. Locate the gurneys with the serial numbers listed in this advisory. 2. If any of the affected gurneys cannot be located, determine if they have been sold, transferred, or donated to another facility and notify us regarding their new location. 3. Verify the brakes are working properly. The brake function may be checked by engaging the brake pedal and pushing on each end of the gurney to make sure that casters are locked securely. 4. Remove the gurneys with non-functioning brakes from service until brake cams have been replaced and brakes are fully functional. 5. Contract Sechrist for the replacement parts package. 6. Complete the retrofit of the Gurney. 7. Verify correct function of the brake assembly following retrofit. 8. Complete and send the Correction Verification Form contained in the package to Sechrist.

Device

Sechrist
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: (all Model Numbers-21502, 21464, 21465, 21466. and 21487) 0604081092 0606087510 0503071536 0503071538 0408061454 0408061455 0408060131 0408061453 0609082336 0604081093 0606087506 0508081371 0508081372 0609082331 0609082333 0609079892 0506069872 0506069875 0601082091 0601082092 0607081892 0607081893 0512070332 0512070337 0604081037 0604081039 0512070333 0601083589 0502072058 0502072219 0504070085 0601083584 0609079893 0502072070 0404059009 0405060916 0406062857 0407058697 0511075672 0610079808 0612087522 0610079809 0505075450 0506070797 0506070799 0508081000 0509074722 0612087681 0612087685 0508080999 0509074952 0408066081 0411068040 0403059871 0403059875 0511075668 0511075670 0505075448 0506069874 0508081375 0508081376 0403060956 0312058058 0312058062 0309052388 0601082095 0509074723 0509074725 0402059070 0402060431 0402060433 0402060435 0502072217 0502072220 0405059703 0503071540 0504070055 0504070057 0504070060 0506070733 0610079810 0509074846 0403060959 0411068039 0606086093 0606086097 0310057034 0310057035 0606086091 0612080504 0603079025 0609082334 0610079806 0609079889 0609082335 0406061037 0409065507 0409065508 0409065509 0409065510 0409065530 0409065532 0409065534 0409067666 0502072216 0608080023 0608080025 0501072513 0501072514 0611079017 0611081316 0504070053 0607081884 0604081423 0605082514 0601083586 0601083588 0606087507 0611081188 0611081192 0505074492 0607081882 0403059872 0403059874 0404059003 0508081334 0508081336 0502077104 0502077105 0502077107 0612087526 0603079027 0506069871 0601082094 0409064823 0409065992 0503071533 0503071534 0408060133 0403060953 0403060958 0409065529 0413060960 0506069883 0506069884 0509074954 0509074959 0309052386 0312058184 0408060132 0408060134 0601083583 0403060523 0403060525 0604081420 0605082515 0502077103 0503071620 0503071621 0503071622 0401059731 0401059732 0612087534 0507073997 0506070701 0403060952 0502071581 0601083585 0601083590 0401059207 0502072218 0508080997 0509074726 0505074497 0606086099 0606086100 0607081881 0608080024 0502071587 0403060957 0409067665 0604081090 0609082439 0611081315 0402060345 0403059959 0403060524 0601082056 0601082057 0608078598 0310057037 0504070052 0505075447 0502072073 0310057030 0609082438 0501071493 0501071494 0502071887 0503071541 0508081333 0509074845 0407060485 0408067475 0403059951 0403059958 0403060051 0409065994 0409065995 0406062858 0406062859 0502071588 0502071589 0403060053 0601082051 0506070702 0506070704 0312052343 0311050367 0502071585 0502071586 0402060341 0402060344 0406062856 0403060955 0611081189 0611081311 0510072561 0511075671 0502072225 0403060954 0601082055 0402060343 0403060521 0604081416 0604081422 0509074842 0509074843 0509074844 0310057036 0312058183 0612087536 0503071539 0504070058 0506070796 0506070798 0506070800 0612087523 0612087525 0406061036 0406066193 0508081374 0309052272 0509074730 0310057029 0612080502 0604081095 0606087901 0403059953 0405059702 0405059704 0612087682 0612087684 0611079016 0611079019 0611081191 0603079023 0604081094 0606087509 0502072055 0502072056 0502072057 0401059203 0401059734 0408061456 0612080501 0612087531 0510072562 0401059205 0612087524 0509074841 0612087533 0612087535 0511075667 0511075669 0409065531 0409065533 0409065535 0406066191 0406066192 0310057032 0311050368 0401059327 0505074499 0506070681 0601082054 0601083587 0403060054 0403060058 0312058182 0507073995 0507073996 0507074000 0409064961 0409064962 0409064963 0606087903 0606087905 0608078597 0608078599 0609079887 0609079891 0506070734 0404059006 0509074956 0509074960 0408067471 0408067472 0403060052 0609082436 0611079020 0502072072 0502072223 0502072224 0401059330 0405060915 0407058699 0407058700 0504070051 0504070054 0407067635 0501071496 0501072515 0405060917 0406061039 0411068041 0411068201 0312058055 0402060342 0612087532 0312052341 0401059328 0401059329 0402059069 0510072560 0510072565 0403059954 0403059955 0312058181 0606087508 0506070682 0510072564 0407067632 0608078596 0507073998 0509074953 0509074955 0607081885 0608080021 0504070059 0506070732 0506070735 0612087686 0401059733 0401059735 0407060481 0407060484 0409067667 0409067668 0403060056 0403060057 0502072074 0402060434 0405059701 0405060914 0411068202 0411068204 0603079024 0502071584 0502071590 0312052342 0312058185 0309052276 0310057028 0310057033 0512070331 0512070335 0611081187 0611081190 0406059343 0407060482 0408061452 0408067474 0501072516 0502071582 0502071583 0502071889 0502071890 0606087904 0607081894 0409065993 0409065996 0610079804 0610079807 0609082337 0403059957 0403059960 0403060055 0406059342 0406061038 0406066194 0403059873 0403060951 0404059007 0404059008 0611079018 0611081313 0411068203 0604081417 0604081091 0509074951 0509074957 0604081418 0604081419 0604081421 0610079805 0509074724 0509074727 0502071888 0502071891 0605082512 0605082516 0510072563 0512070334 0607081891 0607081895 0506069873 0506069881 0506069882 0506069885 0612087521 0507073999 0611081312 0611081314 0502072222 0503071623 0503071624 0504070056 0505075446 0505075449 0506070731 0605082510 0605082511 0509074721 0508080994 0502077106 0505074494 0505074498 0309052387 0612087683 0604081036 0604081040 0605082513 0601082093 0601082096 0404059001 0404059005 0404059010 0508080991 0508080996 0310057031 0508080992 0508080993 0505074491 0505074500 0504070081 0504070082 0609082332 0612080505 0508081335 0508081373 0612080503 and 0612080506
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide-USA, Brazil, Bulgaria, Canada, Dubai, U.A.E., Estonia, India, Indonesia, Japan, Malaysia, Saudi Arabia, Sweden, Taiwan, Thailand, and Vietnam.
  • 제품 설명
    Sechrist Hyperbaric Chamber Gurney, Standard Gurney Without Siderails & Stretcher Model, P/N 21487, Sechrist Industries, Inc., Anaheim, CA
  • Manufacturer
    Sechrist Industries Inc

Manufacturer

Sechrist Industries Inc
  • 제조사 주소
    Sechrist Industries Inc, 4225 E La Palma Ave, Anaheim CA 92807-1815
  • 제조사 모회사 (2017)
    Sechrist Industries Inc.
  • Source
    USFDA