Events

Device Recall AXIOM Sireskop SD 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Siemens Medical Solutions USA, Inc 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
    51560
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1254-2009
  • 사례 시작날짜
    2009-01-08
  • 사례 출판 날짜
    2009-05-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2009-09-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=80863
  • 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
    Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
  • 원인
    During interventional use and applications, the possibility exists for liquids to enter the systems.
  • 조치
    A Customer Safety Advisory Notice dated January 8, 2009 was issued to affected customers via Update Instructions AX069/08/S. This letter informed customers of the potential issues and provided instructions to avoid its occurrence. The firm has released an Addendum to the User Manual warning of the potential hazards if liquids penetrate the systems during interventional use and applications. Direct questions about this recall to Siemens Medical Solutions USA, Inc. by calling 1-610-219-6300.

Device

Device Recall AXIOM Sireskop SD
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers: 51010, 71136, 51007, 51008, 71019, 71080, 71172, 71067, 41012, 71015, 71038, 71102, 71104, 71169, 51006, 51011, 51024, 51028, 71026, 71039, 71083, 71117, 71119, 41027, 71120, 71121, 41028, 71137, 71138, 71149, 71158, 71161, 71167, 71168, 71170, 51060, 71160, 51026, 71030, 71059, 71033, 71037, 41006, 51052, 51064, 71001, 71082, 71114, 71141, 71148, 71152, 71156, 51046, 71181, 51013, 51044, 71075, 71098, 51054, 71020, 71021, 71074, 71088, 41026, 71135, 71140, 71055, 71006, 71017, 71042, 71073, 71162, 71174, 41003, 51049, 71053, 71128, 71131, 41022, 71096, 71099, 71129, 51009, 51036, 51045, 71069, 71087, 71144, 41008, 71014, 71016, 71028, 71109, 71130, 71004, 71051, 71090, 71157, 51029, 51030, 51069, 71009, 71011, 71034, 71035, 71126, 71127, 71145, 51003, 51016, 71022, 71029, 71164, 51043, 51070, 71061, 71064, 71110, 71116, 51001, 51057, 41014, 71124, 71133, 51012, 51050, 71070, 71142, 71095, 41011, 51047, 71023, 71076, 71081, 71084, 51041, 41010, 71032, 41029, 71002, 71065, 71105, 71115, 51005, 71068, 51017, 51018, 51023, 71043, 71046, 41020, 71091, 71092, 71101, 71108, 71139, 71146, 71150, 71155, 71178, 51015, 51059, 51066, 71013, 71057, 71062, 71097, 41013, 71024, 41023, 71086, 51037, 71010, 71106, 71112, 51065, 51068, 71008, 41017, 71078, 41024, 71079, 71111, 71018, 71147, 51002, 71040, 41002, 51019, 51020, 41005, 51033, 41007, 51040, 51048, 51051, 51055, 51061, 71003, 71007, 71012, 41018, 71025, 41019, 71045, 71063, 71100, 71103, 71113, 71122, 71125, 71153, 71154, 71159, 71163, 71171, 71173, 71177, 51004, 51021, 51025, 51058, 71048. 71058, 71060, 71072, 41001, 51022, 51031, 51035, 51039, 71027, 71175, 51063, 71005, 71066, 71089, 71165, 71166, 71123, 71151, and 51056.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution.
  • 제품 설명
    AXIOM Sireskop SD Model numbers 8890415 and 8890407. The product is intended for use as radiographic and fluoroscopic imaging device.
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • 제조사 주소
    Siemens Medical Solutions USA, Inc, 51 Valley Stream Pkwy, Malvern PA 19355
  • 제조사 모회사 (2017)
    Siemens Ag
  • Source
    USFDA