Events

Device Recall Shimadzu YSF300 XRay Diagnostic Table 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Shimadzu Medical Systems 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
    73745
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1585-2016
  • 사례 시작날짜
    2016-03-31
  • 사례 출판 날짜
    2016-04-28
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-01-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144860
  • 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
    Table, radiographic, tilting - Product Code IXR
  • 원인
    Report of unintentional movement of table to reverse tilting.
  • 조치
    Shimadzu sent an Urgent Voluntary Medical Device Recall Notice to all affected customers on April 8, 2016. Shimadzu Corporation has identified a potential issue in the Shimadzu X-ray Diagnostic Table. The letter informs the customers of the problems identified and the actions to be taken. Customers with questions or concerns are instructed to contacted Shimadzu National Technical Support at (800) 228-1429. Shimadzu will send out an updated customer notification letter to inform customers that the liquid penetration may cause an electrical short circuit, causing the table to unintentionally tilt in reverse. If this unintentional reverse tilting occurs, there is a potential risk of injury to the patient and/or the user. For questions regarding this recall call 310-217-8855, ext 139.

Device

Device Recall Shimadzu YSF300 XRay Diagnostic Table
  • 모델명 / 제조번호(시리얼번호)
    Serial No. 0162A80301 0162A80302 0162A80303 0162A80401 0162A80403 0162A81001 0162A81002 0162A81003 0162A81101 0162A81102 0162A81103 0162A81104 0162A81105 0162A81106 0162A81301 0162A81302 0162A81303 0162A81304 0162A81501 0162A81502 0162A81503 0162A81504 0162A81505 0162A81601 0162A81602 0162A81603 0162A81701 0162A81702 0162A81703 0162A81704 0162A81705 0162A81801 0162A81803 0162A82101 0162A82102 0162A82202 0162A82203 0162A82301 0162A82302 0162A82501 0162A82502 0162A82601 0162A82602 0162A82701 0162A82702 0162A82703 0162A82801 0162A82802 0162A82902 0162A83001 0162A83002 0162A83101 0162A83201 0162A83202 0162A83301 0162A83302 0162A83401 0162A83501 0162A83502 0162A83601 0162A83602 0162A83702 0162A83801 0162A83901 0162A83902 0162A84001 0162A84101 0162A84102 0162A84201 0162A84202 0162A84203 0162A84301 0162A84302 0162A84401 0162A84402 0162A84501 0162A84502 0162A84601 0162A84602 0162A84701 0162A84702 0162A84802 0162A84901 0162A84902 0162A85001 0162A85002 0262A80101 0262A80102 0262A80201 0262A80202 0262A80301 0262A80302 0262A80501 0262A80502 0262A80701 0262A80702 0262A80801 0262A80802 0262A80901 0262A80902 0262A81001 0262A81101 0262A81202 0262A81301 0262A81302 0262A81401 0262A81402 0262A81501 0262A81502 0262A81601 0262A81701 0262A81702 0262A81801 0262A81802 0262A81902 0262A82002 0262A82101 0262A82102 0262A82201 0262A82202 0262A82402 0262A82502 0262A82601 0262A82701 0262A82702 0262A82901 0262A83201 0262A83202 0262A83401 0262A83501 0262A83502 0262A83602 0262A83701 0262A83702 0262A83801 0262A83802 0262A83902 0262A84101 0262A84102 0262A84201 0262A84302 0262A84401 0262A84501 0262A84502 3YAFC840A002 3YAFC840A003 3YAFC840A004 3YAFC8411001 3YAFC8413001 3YAFC8415001 3YAFC8415002 3YAFC8418001 3YAFC8418002 3YAFC841A001 3YAFC841A002 3YAFC841B001 3YAFC841B002 3YAFC841C001 3YAFC841C002 3YAFC8422001 3YAFC8422002 3YAFC8422003 3YAFC8425001 3YAFC8425002 3YAFC8427001 3YAFC8427002 3YAFC8427003 3YAFC8428001 3YAFC8428002 3YAFC8428003 3YAFC8428004 3YAFC842A001 3YAFC842A002 3YAFC842C001 3YAFC842C002 3YAFC8433001 3YAFC8442001 3YAFC8443001 3YAFC8444001 3YAFC8446001 3YAFC8448001 3YAFC8449001 3YAFC8453001 3YAFC8458001   0262A84301
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    X-Ray Diagnostic Table, Model No. YSF-300 || Use in combination with an X-ray high voltage generator, an X-ray tube unit, an Image intensifier and X-ray television unit, this table is applied for the following X-ray examinations: -X-ray T.V. fluoroscopy -Spot-filming -Bucky radiography
  • Manufacturer
    Shimadzu Medical Systems

Manufacturer

Shimadzu Medical Systems
  • 제조사 주소
    Shimadzu Medical Systems, 20101 S Vermont Ave, Torrance CA 90502-1328
  • 제조사 모회사 (2017)
    Shimadzu Corp.
  • Source
    USFDA