Events

Allen Bow 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-0641-2018
  • 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=161647
  • 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

Allen Bow Frame
  • 모델명 / 제조번호(시리얼번호)
    Serial Number: A402596 A404960 A407142 A408656 A411816 A415114 A416956 A402597 A404961 A407143 A408657 A411817 A415115 A416957 A402598 A404962 A407144 A408658 A411818 A415116 A416958 A402599 A404963 A407145 A409320 A411819 A415117 A416959 A402604 A404964 A407146 A409321 A411820 A415726 A416960 A402605 A404965 A407460 A409322 A412539 A415727 A416961 A402606 A404966 A407147 A409323 A412540 A415728 A417547 A402607 A405472 A407461 A409335 A412541 A415729 A417548 A402608 A405473 A407885 A409336 A412542 A416163 A417549 A402609 A405474 A407886 A410068 A412543 A416164 A417550 A402610 A405475 A407887 A410069 A412544 A416165 A417919 A402611 A405476 A407888 A410070 A412545 A416166 A543137 A403277 A405477 A407889 A410071 A412546 A416167  A403278 A405478 A407890 A410072 A413529 A416168  A403279 A405479 A407891 A410073 A413530 A416169  A403280 A405787 A407892 A410074 A413531 A416170  A403281 A405788 A407893 A410075 A413532 A416270
  • 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
    Allen Medical Bow Frame Model A-70800. 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