Events

AXIOM ICONOS X-ray System Technical Name: X-Ray Fluoroscopic System ANVISA Registration Number: 10234230063 Hazard Class: III Affected Model: R100, R200 Serial Numbers Affected: 4603, 10021, 10024, 10025, 10026, 10034, 10039, 10039, 10019, 10243, 10244, 11000, 11003, 11018, 11101, 11113, 12005, 12018, 12111, 12132, 12133, 12192, 12194, 12123, 12223, 12401, 12403, 12405, 12406 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Siemens Healthcare Diagnósticos S.A; SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD. 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
  • 사례 ID
    2264
  • 날짜
    2017-04-20
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 비고 / 경고
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • 데이터 추가 비고
    The user must avoid any collision of the table with objects in the operating area of ​​the table. In the event of a collision, it is mandatory to carry out a preventive inspection by the SIEMENS Technical Assistance Service which should be contacted immediately if a collision of this type occurs. ### UPDATED ON 10/26/2017, the company presented the completion report of the field action proving the sending of the security warning to the client with evidence of science and all actions completed.
  • 원인
    Siemens healthcare diagnostics has identified a potential malfunction of the equipment in the event of an accident such as a collision of the table, resulting in risk to patients and employees with systems icons r20 icons c20, r200 icons t20, r100 icons, md icons, rhd icons, rf luminos classic, luminos fusion or luminos select. this malfunction is possible in cases where the vertical tilt movement of the table is obstructed by a solid object (eg a patient stool or ladder), resulting in a collision.
  • 조치
    Field Action Code XP063 / 12 / S triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will send Letter to the Client.

Device

AXIOM ICONOS X-ray System Technical Name: X-Ray Fluoroscopic System ANVISA Registration Number: 1...

Manufacturer

Siemens Healthcare Diagnósticos S.A; SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD.