Events

Device Recall Philips 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
    61204
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1216-2012
  • 사례 시작날짜
    2012-02-14
  • 사례 출판 날짜
    2012-03-15
  • 사례 상황
    Completed
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107557
  • 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
    System, x-ray, stationary - Product Code KPR
  • 원인
    Misinterpretation of mirror icon-mirror icon on the bottom of each image could be misinterpreted as a right lead marker for side indication if the image is mirrored within a pacs system.
  • 조치
    Philips Healthcare sent an Urgent Medical Device Correction letter dated February 8, 2012 to all affected customers. The letter identified the affected product, problem description, hazard involved, actions to be taken by customer/user and actions planned by Philips. The letter contains important information for continue safe and proper use of the equipment. Philips will contact customers to schedule the installation of the updated software. For further information or support contact your local Philips representative at the Technical Support Line 866-767-2822.

Device

Device Recall Philips
  • 모델명 / 제조번호(시리얼번호)
    DRF systems with software reI 3.0 and 3.1 S/N: 362600 362601 364209 364210 375245 375850 376439 416254/SN09000007 417890/SN08000120 384396 401281/SN08000142 399440 387492 399621 398185 423047 399623 422094 422823 412477/SN08000137 425981 402409 402410/SN08000112 428620 428623 426466 426467 404548/SN08000110 417116/SN08000126 410563/SN08000120 408593/SN08000103 408592/SN08000111 408237/SN08000115 409087/SN08000107 435412 413514/SN08000123 413831/SN08000122 422648 422650 422652 414463 416393/SN08000140 416643/SN09000005 420212 421780 420872/SN09000003 425745 425744 427503 435926 430916 H706034090029 429498 431820 435419 439922 432277 435422
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA Nationwide
  • 제품 설명
    Philips EasyDiagnost Eleva DRF, Fluoroscopic x-ray system || Software Release 3.0 and 3.1 || Model: 706034 || Product Usage: Radiological image processing system (computed radiography x-ray system)
  • 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