Events

Device Recall E.CAM PHS Field of View Indicator Bars 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Siemens Medical Solutions USA, Inc. 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
    50773
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1505-2009
  • 사례 시작날짜
    2008-12-18
  • 사례 출판 날짜
    2009-06-24
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-05-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=77136
  • 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
    emmission tomography accessory - Product Code KPS
  • 원인
    Patient fingers can get pinched if they attempt to pull themselves up from the patient handling system without any assistance and grabbing onto the flip-up fov indicator bars.
  • 조치
    Siemens sent Urgent Field Correction Recall letters dated 12/18/08 to all users of the E.cam Systems. The accounts were informed of the potential risk to patients when they attempt to pull themselves up from the patient handling system (PHS) without any assistance and grabbing the field of view (FOV) indicator bar (aka flip-up armrests). The customers were advised to always assist the patient when getting on/off of the PHS. They also were advised that a Siemens Customer Service Representative would contact them within 90 days to schedule a corrective upgrade to the PHS with a modified FOV guide to mitigate the risk for patient injury free of charge. Any questions were directed to contact Siemens Medical Solutions USA, Inc. at 1-800-767-2313 (USA) for assistance.

Device

Device Recall E.CAM PHS Field of View Indicator Bars
  • 모델명 / 제조번호(시리얼번호)
    part number 43 66 618 (right) and 43 81 088 (left), serial numbers 00001 to 04031
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA, Guam, Argentina, Australia, Austria, Bangladesh, Belgium, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Czech Republic, Ecuador, Egypt, Finland, France, Germany, Great Britain, Hong Kong, India, Ireland, Israel, Italy, Japan, Korea, Latvia, Lebanon, Mauritius, Mexico, Myanmar, Netherlands, New Zealand, Norway, Pakistan, Peru, Philippines, Poland, Portugal, Russia, Saudi Arabia, Spain, Sweden, Switzerland, Taiwan, Turkey and United Arab Emirates.
  • 제품 설명
    Siemens Medical Solutions E.CAM Patient Handling System (PHS) Field of View (FOV) indicator bars; a component of the E.CAM Emission Computed Tomography System; part number 43 66 618 (right) and 43 81 088 (left).
  • Manufacturer
    Siemens Medical Solutions USA, Inc.

Manufacturer

Siemens Medical Solutions USA, Inc.
  • 제조사 주소
    Siemens Medical Solutions USA, Inc., 2501 Barrington Rd, Hoffman Estates IL 60195-2061
  • 제조사 모회사 (2017)
    Siemens Ag
  • Source
    USFDA