Events

Precision 500D, Legacy, RFX, and SFX X-ray imaging systems 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 GE Healthcare 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 날짜
    2013-10-02
  • 사례 출판 날짜
    2013-10-02
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131002a.html
  • 비고 / 경고
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • 데이터 추가 비고
    Medical Device Safety Alert
  • 원인
    Medical device safety alert: ge healthcare precision 500d, legacy, rfx, and sfx x-ray imaging systems the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning precision 500d, legacy, rfx, and sfx x-ray imaging systems, manufactured by ge healthcare. the affected part numbers are 2258627, 2305472, 2305495, 2404103, 2403791, 2403791-3, 2403791-32, 2403791-40, 46-262751g2, 46-262751g4, 46-262751g5, 46-262751g6, 46-262751g7, and 46-262751g8. there is a potential for the internal bolts on the power assist handle to be loose or to loosen and/or fall out. this issue, if present, can result in a loss of calibration and offset of the power assist handle and/or, under extreme condition, sticking of the handle in the on position, and causing the system to strike the patient. no injuries have been reported to date related to this issue. the manufacturer advises users to inspect power assist handle for either of the two conditions listed below, and immediately contact local ge healthcare service representative if any issue is found. if users observe that the power assist handle plastic grip is loose relative to the mount, discontinue use. if plastic grip is secure, but users observe erratic performance, (power assist unresponsive, drifting of spotfilm device with no command, or lock release always on), users may continue to use the device with care. use all safety precautions relative to application of the myelographic stop and the inhibit, table horizontal stop off. furthermore, ge healthcare will correct all affected systems. for details, please refer to mhra website http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con316301 if you are in possession of the product, please contact your supplier for necessary actions. posted on 2 october 2013.

Device

Precision 500D, Legacy, RFX, and SFX X-ray imaging systems
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: GE Healthcare Precision 500D, Legacy, RFX, and SFX X-ray imaging systems
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare