Stealth(TM) Chamber 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Iba Dosimetry 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
    77301
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2220-2017
  • 사례 시작날짜
    2017-04-26
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2018-06-11
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Accelerator, linear, medical - Product Code IYE
  • 원인
    When the stealth chamber is used as a reference detector in relative dosimetry, deviation in the measured pdds at shallow depths and geometric shadowing of measured profiles may appear.
  • 조치
    IBA Dosimetry sent an Field Safety Notice dated April 21, 2017. The letter informed the consignee of the issue and provided the following instruction: If a Stealth Chamber was used during commissioning of Linear Accelerator and Treatment Planning System, the consignee was asked to consider referenced deviations for larger field sizes (>20 x 20 cm) and higher energies (>60MV). They were also instructed to recheck the influence of the PDD deviation and insufficient clearance for 40 x 40 profile on their beam model and its clinical relevancy. For further questions please call (901) 268-6430. Contact information Should you have questions or require additional information, please contact the Customer Service Team at:: South and Middle America, USA, and Canada : IBA Dosimetry America Bartlett, TN, USA US Service@.iba-group .com Phone: +1 901 386-2242 Fax: +1 901 382-9453 Asia Pacific, A Australia and New Zealand: IBA China, Dosimetry Dept. Beijing, China Service APAC@.iba-group .com Phone: +86 10 8080 9107 Fax: + 86 10 80809298 All other countries: IBA Dosimetry GmbH, Service Dept. Schwarzenbruck , Germany service@.iba-group .com Phone: +49 9128 607-38 Fax: +49 9128 607-26

Device

  • 모델명 / 제조번호(시리얼번호)
    DS50-001-XL-T, Serial Numbers: 24887, 25084, 25085  DS50-002-XL-T, Serial Numbers: 24185, 25219, 25470, 24073, 24187, 24480, 24888, 25089, 24889, 24184, 24813, 24814, 24866, 24867, 24890, 25088, 25220, 24482, 24186, 25090, 24626, 24074, 24189, 25218, 25468, 25469  DS50-003-XL-T, Serial Numbers: 24437, 24260, 24639, 25472, 24257, 24291, 24630, 24640, 24868, 25093, 25478, 24180, 24182, 24259, 24323, 24439, 25222, 24179, 24290, 24293, 24633, 24637, 25091, 25223, 24627, 24077, 24634, 24438, 25476, 25221, 24292, 24263, 24322, 24435, 24628, 24642, 25094, 25479, 24177, 24178, 24641, 25481, 24261, 24076, 24871, 25224, 24078, 24079, 24080, 24175, 24176, 24183, 24256, 24258, 24262, 24264, 24265, 24289, 24321, 24436, 24629, 24631, 24635, 24636, 24638, 24869, 24891, 24892, 24893, 24894, 24896, 24897, 25092, 25095, 25225, 25477  DS50-102-XL-T, Serial Numbers: 24190, 24481, 25467  DS50-103-XL-T, Serial Numbers: 24870, 24898
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and to the countries of : Argentina, Australia, Austria, Canada, Cyprus, France, Germany, Hong Kong, Ireland, Islamic Republic of, Israel, Italy, Japan, Kingdom of Saudi Arabia, Kuwait, New Zealand, People's Republic of China, Philippines, Russia, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, R.O.C., and United Kingdom.
  • 제품 설명
    Large Stealth Chamber, Catalog Numbers: DS50-001-XL-T, DS50-002-XL-T, DS50-003-XL-T, DS50-102-XL-T, DS50-103-XL-T
  • Manufacturer

Manufacturer

  • 제조사 주소
    Iba Dosimetry, 3150 Stage Port Drive, Suite 110, Bartlett TN 38133
  • Source
    USFDA