Events

System, Xray Stationary 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Philips Healthcare 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
    63119
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2465-2012
  • 사례 시작날짜
    2012-09-06
  • 사례 출판 날짜
    2012-09-27
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-01-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112650
  • 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
    Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
  • 원인
    The wireless portable detector (wpd) is not fixed securely inside the mobile detector holder and may fall down.
  • 조치
    Philips Healthcare sent a Urgent Field Safety Notice dated August 13, 2012, to all affected customers. Notifications began the week of September 6, 2012, for US and Worldwide Customers. The letter identified the product the problem and the action needed to be taken by the customer. Philips field service engineer will Secure the 4 countersunk screws, which are used to attach the lock mechanism, with thread locker (loctite). Further information or support concerning this issue, contact your local Philips representative. 1-800-722-9377.

Device

System, Xray Stationary
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: SN10000053 SN11000644 SN10000648 SN10000649 SN11000226 SN10000703 SN11000032 SN10000407 SN11000105 SN11000112 SN11000212 SN11000231 SN11000030 SN10000468 SN11000146 SN11000217 SN11000238 SN11000407 SN11000154 SN10000297 SN10000515 SN11000129 SN11000266 SN11000412 SN11000442 SN11000063 SN11000441 SN10000416 SN10000414 SN10000424 SN11000034 SN10000018 SN11000050 SN10000113 SN10000442 SN11000057 SN11000419 SN10000482 SN10000670 SN10000690 SN10000689 SN10000694 SN11000461 SN10000544 SN11000095 SN11000329 SN11000464 SN10000554 SN10000635 SN10000107 SN10000413 SN10000557 SN11000092 SN11000100 SN11000118 SN11000145 SN11000161 SN11000193 SN11000194 SN11000228 SN11000294 SN11000371 SN10000038 SN10000101 SN10000102 SN10000641 SN10000664 SN11000027 SN10000537 SN10000650 SN11000130 SN11000142 SN11000216 SN11000269 SN11000286 SN11000288 SN11000311 SN11000320 SN10000363 SN10000246 SN10000512 SN11000033 SN11000053 SN11000080 SN11000271 SN11000478 SN11000474 SN11000013 SN11000005 SN11000008 SN11000004 SN11000141 SN11000007
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution--USA (nationwide) and the countries of Australia, Austria, Canada, Chile, Finland, France, Germany, Hungary. Italy, Japan, Latvia, Netherlands, New Zealand. Oman, South Korea, Switzerland and United Kingdom.
  • 제품 설명
    Philips Digital Diagnost-Mobile Detector Holder for Digital Diagnost (Single Detector, Dual Detector, Release 3) || System codes: 712020, 712022, 712025 || This system is used for making X-ray exposures for diagnostics.
  • Manufacturer
    Philips Healthcare Inc.

Manufacturer

Philips Healthcare Inc.
  • 제조사 주소
    Philips Healthcare Inc., 3000 Minuteman Road, Andover MA 01810
  • 제조사 모회사 (2017)
    Philips
  • Source
    USFDA