Events

RITA 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Rita Medical Systems 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
    27500
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0087-04
  • 사례 시작날짜
    2003-10-06
  • 사례 출판 날짜
    2003-11-01
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2004-05-05
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29976
  • 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
    Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
  • 원인
    The product displays inaccurate temperature readings, patient skin burns can occur before getting to higher temperature reading.
  • 조치
    On 10/6/03, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected devices and providing instructions on the recall.

Device

RITA
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers: Y072103-3, Y082003
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Product was released for distribution to 66 consignees in US. The product received nationwide distribution. The recall was appropriately extended to the user level; i.e., the hospitals that received the recalled product. There were no shipments to foreign or Canadian distribution, however, it includes one military distribution: Wilford Hall Medical Center, 2200 Berquist Dr., 31, Lackland AFB, TX 78236.
  • 제품 설명
    RITA brand ThermoPad, Electrosurgical RF Generator and accessories || Part Number: 700-102649
  • Manufacturer
    Rita Medical Systems

Manufacturer

Rita Medical Systems
  • 제조사 주소
    Rita Medical Systems, 967 N Shoreline Blvd, Mountain View CA 94043-1932
  • Source
    USFDA