Events

Device Recall Integra InterFix CT Adapter (CTA) 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Integra LifeSciences Corp 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
    61131
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1187-2012
  • 사례 시작날짜
    2012-01-23
  • 사례 출판 날짜
    2012-03-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-10-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107363
  • 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
    Material used in the superior region of the interfix ct adapter (cta) has a different density than that of the treatment table couch adapter (tta). resulting dosimetry can be affected if posterior fields are used. integra estimates that a target dose decrease of 1.2% would result from a typical 360 degree tomotherapy arc.
  • 조치
    Integra sent a Product Technical Bulletin dated January 23, 2012, to all affected consignees via FedEx, email or telephone conference calls. The revised Operator Manual was provided with a Technical Bulletin to all consignees that have been shipped this system. Consignees were asked to distribute the information in the bulletin to members of the Radiotherapy Planning Team within their institution. Customers were also asked to sign and return the enclosed Product Technical Bulletin Acknowledgement Form. For questions regarding this recall call 888-772-7378.

Device

Device Recall Integra InterFix CT Adapter (CTA)
  • 모델명 / 제조번호(시리얼번호)
    Lot Number: 113820 114121 114430 114586 117771 121402 130169 131122 133760 133810 135008 135429 135429 141074 141563 143905 143905 148028 154133 155785 161426 166069 168862 172321 172321 182007 186253 189940 195330 195330 237711 2 units no lot number identified
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including DC, IN, FL, HI, LA, NY, MD, MI, OH,OR, WI, WY, Foreign: Great Britain, Italy, and France
  • 제품 설명
    Integra InterFix CT Adapter (CTA) || Intended for cranial fixation during CT scanning and || treatment with the TomoTherapy HiArt (Torno) System || The Integra InterFix CT Adapter (CTA) kits are intended for cranial fixation during CT and and treatment with the Tomo Therapy Hi-Art system. Provides adapters for attaching: Integra head rings to the following: 1.Flat CT scanner tabletops ranging form 47cm to 54 cm 2. TomoTherapy Hi-Art system tabletop
  • Manufacturer
    Integra LifeSciences Corp

Manufacturer

Integra LifeSciences Corp