Events

Rapid Strand Rx 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Medi-Physics Inc. dba GE Healthcare 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
    60005
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0266-2012
  • 사례 시작날짜
    2011-09-20
  • 사례 출판 날짜
    2011-11-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-01-20
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104223
  • 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
    Source, brachytherapy, radionuclide - Product Code KXK
  • 원인
    There is a potential brachytherapy over or under dose with the rapid strand rx kit that may impact patient therapy.
  • 조치
    GE Healthcare/Oncura sent a "Urgent Medical Device Correction" letter dated September 20, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customers were advised to assess the pre and post plan dosimetry for their patient, taking into account the possible variation of the seed strength. GE Healthcare/Oncura will contact the customers in the near future to confirm their receipt of the letter and to discuss any questions they may have. Please call if you have any further questions (847) 398-8400 and 011-44-1494-737251 (Amersham, United Kingdom, GMT)

Device

Rapid Strand Rx
  • 모델명 / 제조번호(시리얼번호)
    product identifier: I125RSRX, Oncura order numbers 85342, 85778, 85897, 87430, 87433, 87479, 87547, 87801, 87849, 87851, 87992, 87993, 88070, 88081, 88093, 88426, 88562, 88690, 88798, 88819, 88823, 88830 and 88844.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution -- USA (nationwide) including the States of Arizona, Florida, Louisiana, Mississippi, New Jersey, New York, Pennsylvania, Puerto Rico, Virginia and Washington, and the countries of Canada and the United Kingdom
  • 제품 설명
    Rapid Strand Rx; the RAPID Strand Rx kit consists of custom loaded absorbable seeding spacers and I-125 radionuclide brachytherapy sources (seeds) spaced at prescribed distance and configuration within a sleeve (tube) made of absorbable suture material, stiffened, loaded into prostate seeding needles, packaged and then sterilized by Gamma sterilization method, accompanied by a calibration strand, a sealed source calibration certificate (100% assay report), a radiograph of the loaded needles in the needle-holding card, and a source certification technical data sheet.; Products Provided by: Oncura, 3350 North Ridge Avenue, Arlington Heights, IL 60004 USA, Prescription Filled by: AnazaoHealth, 5710 Hoover Blvd., Tampa, FL 33634 USA; product identifier: I125RSRX, model 7000. || RAPID Strand Rx is indicated for permanent interstitial implantation of selected localized tumors that are of low to moderate radio sensitivity. It may be used either as primary treatment (such as prostate cancer or unresectable tumors) or for the treatment of residual disease after excision of the primary tumor. RAPID Strand Rx may be indicated for use concurrent with or at the completion of other treatment modalities such as external beam radiation therapy.
  • Manufacturer
    Medi-Physics Inc. dba GE Healthcare

Manufacturer

Medi-Physics Inc. dba GE Healthcare
  • 제조사 주소
    Medi-Physics Inc. dba GE Healthcare, 3350 N Ridge Ave, Arlington Heights IL 60004-1412
  • 제조사 모회사 (2017)
    General Electric Company
  • Source
    USFDA