Events

Device Recall Mayfield Infinity XR2 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Integra LifeSciences Corporation 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
    55852
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2336-2010
  • 사례 시작날짜
    2010-05-19
  • 사례 출판 날짜
    2010-09-09
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-10-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92040
  • 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
    Operating Room Accessories Table Tray - Product Code FWZ
  • 원인
    Storage case incorrectly labeled. the labels were for the infinity xr2 skull clamp storage containers but were inadvertently placed on the infinity xr2 base unit storage cases.
  • 조치
    The firm, Integra Life Sciences Corporation,contacted their customers via telephone and Field Correction Letter on May 19, 2010 to notify their customers of the problem. The firm indicated that their sales representatives will visit the consignees affected, correct the case labeles according to the specific instructions indicated, revise their account tracebility records to reflect the labeling change, then, sign and return the Acknowledgement of Reciept and Return Form for confirmation. For questions regarding the correction, please contact Integra Life Sciences Corporation at (877) 44-1114 or (513) 533-7923.

Device

Device Recall Mayfield Infinity XR2
  • 모델명 / 제조번호(시리얼번호)
    Reference number A-2079, Serial number(s) XB091031, XB091032, XB091033, XB091034, XB091035, XB091036, XB091037, XB091038, XB091039, XB091040, XB091041, XB091042, XB091043, XB091044, XB091045, XB091046, XB091047, XB091048, XB091049, XB091050
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Product was shipped to the following states: IN, MO, NJ, TX and VA. Product was also sold in Belgium, Canada and New Zealand.
  • 제품 설명
    Mayfield Infinity XR2 Base Unit, model A-2079, manufactured by Integra LifeSciences Corporation. The MAYFIELD Infinity XR2 Base Unit (A-2079) is an operating room table accessory intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp is necessary, positional freedom is required and where x-ray imaging modalities will be used.
  • Manufacturer
    Integra LifeSciences Corporation

Manufacturer

Integra LifeSciences Corporation