Events

Quickie Rhythm, Quickie Groove, and Quickie Zippy ZBop 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Sunrise Medical 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
    38309
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1163-2007
  • 사례 시작날짜
    2007-04-23
  • 사례 출판 날짜
    2007-08-14
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2008-03-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53384
  • 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
    Wheelchairs powered - Product Code ITI
  • 원인
    The wire harness connected to the display housing (quickie iq enhanced displays) may separate and cause sparks from a short circuit.
  • 조치
    Firm contacted consignees by phone and mailed May 1, 2007, Urgent Medical Device notification letters.

Device

Quickie Rhythm, Quickie Groove, and Quickie Zippy ZBop
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: USA Rhythm SIN RTM-100023 RTM-100095 RTM-100152 RTM-100278 RTM-100492 RTM-100499 RTM-100510 RTM-100513 RTM-100516 RTM-100597 RTM-100606 RTM-100702 RTM-100703 RTM-100710 RTM-100733 RTM-100823 RTM-100840 RTM-100846 RTM-100854 RTM-101103 RTM-101111 RTM-101112 RTM-101118 RTM-101159 RTM-101166 RTM-101167 RTM-101169 RTM-101174 RTM-101177 RTM-101184 RTM-101188 RTM-101215 RTM-101242 RTM-101252 RTM-101260 RTM-101262 RTM-101264 RTM-101268 RTM-101269 RTM-101271 RTM-101285 RTM-101302 RTM-101309 RTM-101312 RTM-101314 RTM-101347 RTM-101391 RTM-101392 RTM-101394 RTM-101429 RTM-101439 RTM-101464 RTM-101468 RTM-101482 RTM-101548 RTM-101550 RTM-101556 RTM-101562 RTM-101565 RTM-101581 RTM-101588 RTM-101593 RTM-101602 RTM-101649 RTM-101670 RTM-101673 RTM-101689 RTM-101702 RTM-101704 RTM-101720 RTM-101735 RTM-101760 RTM-101761 RTM-101778 RTM-101782 RTM-101798 RTM-101826 RTM-101842 RTM-101854 RTM-101857 RTM-101866 RTM-101867 RTM-101876 RTM-101886 RTM-101892 RTM-101901 RTM-101904 RTM-101911 RTM-101916 RTM-101925 RTM-101941 RTM-101947 RTM-101959 RTM-101974 RTM-101990 RTM-101994 RTM-101997 RTM-102018 RTM-102023 RTM-102024 RTM-102026 RTM-102031 RTM-102033 RTM-102039 RTM-102052 RTM-102053 RTM-102058 RTM-102080 RTM-102081 RTM-102082 RTM-102095 RTM-102106 RTM-102123 RTM-102140 RTM-102144 RTM-102147 RTM-102151 RTM-102153 RTM-102155 RTM-102156 RTM-102164 RTM-102169 RTM-102201 RTM-102204 RTM-102218 RTM-102230 RTM-102237 RTM-102247 RTM-102249 RTM-102253 RTM-102257 RTM-102258 RTM-102264 RTM-102268 RTM-102270 RTM-102271 RTM-102272 RTM-102287 RTM-102298 RTM-102301 RTM-102303 RTM-102315 RTM-102329 RTM-102333 RTM-102344 RTM-102345 RTM-102348 RTM-102363 RTM-102393 RTM-102396 RTM-102397 RTM-102400 RTM-102414 RTM-102429 RTM-102442 RTM-102447 RTM-102462 RTM-102464 RTM-102468 RTM-102474 RTM-102479 RTM-102484 RTM-102490 RTM-102495 RTM-102516 RTM-102523 RTM-102530 RTM-102535 RTM-102571 RTM-102574 RTM-102601 RTM-102602 RTM-102608 RTM-102610 RTM-102611 RTM-102616 RTM-102637 RTM-102639 RTM-102643 RTM-102647 RTM-102659 RTM-137762  Groove S/N GRV-100053 GRV-100059 GRV-100081 GRV-100096 GRV-100203 GRV-100222 GRV-100226 GRV-100228 GRV-100233 GRV-100266 GRV-100267 GRV-100273 GRV-100280 GRV-100287 GRV-100297 GRV-100317  Z-Bop S/N 1 GM01 BB600080 1 GM01 BC600062 1GM01 BC600014  International Rhythm S/N RTM-100516 RTM-100873 RTM-101403 RTM-101423 RTM-101427 RTM-101434 RTM-101580 RTM-101796 RTM-101850 RTM-101954 RTM-101999 RTM-102124 RTM-102129 RTM-102311 RTM-102312 RTM-102376 RTM-OMIT159372  Groove S/N GRV-100166 GRV-100312
  • 의료기기 분류등급
    Physical Medicine Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Product was distributed Worldwide.
  • 제품 설명
    Sunrise Medical Quickie Power Wheelchairs: Three models -Rhythm, Groove, and Zippy Z-Bop (with Quickie IQ Enhanced Displays)
  • Manufacturer
    Sunrise Medical Inc

Manufacturer

Sunrise Medical Inc
  • 제조사 주소
    Sunrise Medical Inc, 2842 N Business Park Ave, Fresno CA 93727-1328
  • Source
    USFDA