Events

Device Recall Sony Inc. 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Sony 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
    71657
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2771-2015
  • 사례 시작날짜
    2015-01-13
  • 사례 출판 날짜
    2015-09-16
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-04-26
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138605
  • 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
    Camera, television, surgical, without audio - Product Code FWB
  • 원인
    Tthe medical monitor has either not turned on or has lost image during clinical use.
  • 조치
    Sony Corporation sent an URGENT: MEDICAL DEVICE FIELD ACTION field letter dated January 13, 2015. Customers are asked to affix the warning sticker to the rear of the monitor and place the adhesive seal over the AC inlet. If the firm does not possess an AC adaptor (AC-110MD) for each of the affected monitors, stop using the monitor and take the monitor out of service until the permanent corrective action described below is implemented.SEL will be replacing the power board of all affected units with a redesigned power board that does not exhibit the appropriate failure mode. Questions can be directed to 866-789-SONY (7669) between 8:00 am and 8:00 pm Monday through Friday.

Device

Device Recall Sony Inc.
  • 모델명 / 제조번호(시리얼번호)
    Sony LMD-1951MD 3000038-3004884, 3100035-3100058, 3100065-3100145   Sony LMD-1951MC (Foreign) 5000001-5001925 5100001-5100157
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Distribution to the states of : AZ, CA, NC, PA, IA, OH and FL., and to the countries of : China, Japan, Taiwan, South Korea and Indonesia.
  • 제품 설명
    Sony LMD-1951MD, Sony LMD1951MD/BS, Sony LMD-1951MC (Foreign) 19 inch medical grade liquid crystal display (LCD) Medical Monitors with light-emitting diode (LED) backlight technology.
  • Manufacturer
    Sony Medical Systems

Manufacturer

Sony Medical Systems
  • 제조사 주소
    Sony Medical Systems, 1 Sony Dr, Park Ridge NJ 07656-8002
  • Source
    USFDA