Events

BV Endura R2.2 Mobile Xray system 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
    49605
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0141-2011
  • 사례 시작날짜
    2008-09-05
  • 사례 출판 날짜
    2010-10-25
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-12-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73917
  • 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
    Mobile X-ray system - Product Code JAA
  • 원인
    Reliability of the stand-trolley cable may result in loss of images on the monitor during an examination. this intermittent problem can lead to system lock-up, where no radiation is possible and images are not visible on the monitor.
  • 조치
    On 10/04/2008, Philips began sending the URGENT-Device Correction BV Pulsera R2.2 and Endura R2.2 letters to their customers. On 09/03/2008, the firm issued the Field Change Order (FCO) 71800024 and the firm's representative will replace the stand-trolley cable free of charge. Customers should contact Philips Call Center at 1-800-722-9377, #5, #2, and reference "FCO 71800024" with any questions.

Device

BV Endura R2.2 Mobile Xray system
  • 모델명 / 제조번호(시리얼번호)
    127 units are identified with Site Numbers:  544982, 546114, 546792, 546793, 547164, 548598, 548686, 548983, 549986, 549987, 550126, 550127, 550281, 550409, 550838, 550959, 551127, 551274, 551492, 551525, 551589, 551695, 551730, 552376, 552393, 552394, 552398, 552444, 552467, 552468, 552669, 552990, 553098, 553171, 553271, 553860, 553917, 553976, 553989, 554350, 554363, 554497, 554507, 554658, 554779, 555001, 555021, 555243, 555395, 555463, 555517, 555821, 556135, 556171, 556192, 556202, 556215, 556531, 556587, 556608, 556612, 556678, 556862, 556947, 556977, 556979, 557037, 557063, 557147, 557510, 557520, 557590, 558233, 558237, 558613, 558868, 558975, 559070, 559663, 559665, 41416327, 41443832, 41443860, 41445126, 41445430, 41445445, 41445552, 41445931, 41446303, 41566246, 41585083, 41630870, 41658558, 41661638, 41765654, 41796621, 41905206, 41938039, 41955473, 41957114, 42045315, 42162893, 42291865, 42326711, 42373518, 42382482, 42394051, 42472756, 42551956, 42608281, 42639034, 42824768, 42861875, 42869100, 42880805, 42966787, 43181969, 43209307, 43209310, 43341471, 43453560, 43618928, 43618930, 43721228, 43722015, 45050110, and 45149708.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution.
  • 제품 설명
    Philips BV Endura R2.2 Mobile X-ray system. The Type Product Code 718074 can be found under the X-ray trolley cover on the front lower right side of the module or under the stand cover. The device brochure is labeled in part: "Philips...Mobile C-Arm system BV Endura".
  • 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