Events

Device Recall OminDiagnost Eleva 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Philips Medical Systems North America Co. Phillips 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
    50742
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0352-2009
  • 사례 시작날짜
    2008-12-10
  • 사례 출판 날짜
    2009-09-24
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-08-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=80530
  • 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
    Angiographic X-Ray System - Product Code JAA
  • 원인
    Tube failure occurs involving fluoroscopy of large patients and a partial failure of the grid switch.
  • 조치
    An Electronic Product Radiation Warning, dated October 2008, was sent to customers. The letter identified the problem and under what circumstances that it could occur; the actions that should be taken by the customer/user to prevent risks for patients or users; and the actions planned by Philips to correct the problem. Further information or support concerning the issue could be obtained by contacting Bob Pettis at 425-487-7469 or the Philips Call Center at 800-722-9377. Firm FCO tracking numbers 72200107, 72200108, 72200111, 72200112, 72200117, 72200118, 72200119, 72200122, 72200123, 72200124, 72200125, 72200129, 72200142, 7989980, 7080085, 70600034, 70600035, 72200132, 72200133, 72200137, 72200138, 72200140 and 72200141. C & R # 1217116-10/20/08-016C

Device

Device Recall OminDiagnost Eleva
  • 모델명 / 제조번호(시리얼번호)
    FCO 70800085 Equipment #'s 102666, 103056, 104083, 104136, 104530, 104838, 105194, 105394, 504340, 504341, 505039, 505345, 505346, 506236, 506247, 519141, 519142, 519574, 519952, 520020, 520046, 521113, 521977, 522220, 530589, 530777, 532087, 532140, 532151, 532213, 532703, 533112, 533314, 533471, 533473, 533559, 534247, 535257, 535714, 535767, 536019, 536091, 536146, 536720, 536935, 537083, 537669, 537787, 539106, 539598, 539990, 540252, 541263, 541490, 543272, 544059, 545014, 545841, 546031, 547017, 547348, 549798, 553676, 558404, 42036161, 42383151, 43180366, 43180367, and 43680651,
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution
  • 제품 설명
    OminDiagnost Eleva
  • Manufacturer
    Philips Medical Systems North America Co. Phillips

Manufacturer

Philips Medical Systems North America Co. Phillips
  • 제조사 주소
    Philips Medical Systems North America Co. Phillips, 22100 Bothell Everett Hwy, Bothell WA 98021-8431
  • Source
    USFDA