Events

Radiolucent Spine Surgery Frame 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Allen 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
    79205
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0642-2018
  • 사례 시작날짜
    2017-10-06
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161648
  • 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, surgical with orthopedic accessories, manual - Product Code JEB
  • 원인
    The base of the frame has the potential to crack when the patient is initially transferred to the bow frame.
  • 조치
    In October of 2017 an Urgent Medical Device Correction letter was sent to customers notifying them of the recall and requesting customers to immediately remove any frames from use that are in the serial number range subject to the recall and that a service technician will coordinate correction of the device. If the device was sent to another company, to forward the recall notice o that person or firm. If you have any questions concerning this Urgent Medical Device Correction, please contact Allen Medical Customer Service at (800) 433-5774, 8:30  5:00 pm EST.

Device

Radiolucent Spine Surgery Frame
  • 모델명 / 제조번호(시리얼번호)
    Serial Number: 533552 536025 536451 539585 539795 535272 536026 536452 539586 542764 535273 536027 536453 539587 544938 535274 536028 536454 539588 544939 535386 536029 536455 539589 544940 535387 536030 536456 539794 546200
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution. US Nationwide, Australia, Bangladesh, Brazil, Canada, China, Denmark, France, Germany, Greece, Italy, Japan, Korea, Kuwait, Lebanon, Malaysia, Netherlands, Spain, Switzerland, Taiwan, UAE, and UK.
  • 제품 설명
    Radiolucent Surgery Spine Frame (F70801). Surgical platform used to position patients for lumbar spine procedures.
  • Manufacturer
    Allen Medical Systems

Manufacturer

Allen Medical Systems
  • 제조사 주소
    Allen Medical Systems, 100 Discovery Way, Acton MA 01720-4481
  • 제조사 모회사 (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA