Events

BV Pulsera Rel 2 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
    50066
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2463-2010
  • 사례 시작날짜
    2008-09-10
  • 사례 출판 날짜
    2010-09-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-01-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74613
  • 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, fluoroscopic, image-intensified - Product Code JAA
  • 원인
    The c-arm rotation brake does not always function properly, and may not hold the c-arm position if the c-arm is not positioned in its maximum rotation and if it is accidentally bumped by medical staff or patients. unwanted c-arm movement may cause the c-arm to collide with a patient. the brakes function properly if the c-arm is rotated to its maximum positions.
  • 조치
    Philips Medical Systems issued an Urgent Product Correction letter dated September 30, 2008 to consignees. The letter identified the affected device, what the problem is and under what circumstances it can occur, and the actions that should be taken by the customer or user in order to prevent risks for patients or users. Philips will contacdt customers to implement Field Corrective Action (FCO) #71800026), which describes a mechanical brake modification which will be installed by Philips. Until the Field Corrective Action has been completed, users should ensure that the C-arm is placed in the maximum extended position, or ensure that the C-arm is not touched during critical procedures if the C-arm is not in a maximum position. The Philips Call Center can be contacted at 800-722-9377

Device

BV Pulsera Rel 2
  • 모델명 / 제조번호(시리얼번호)
    Devices are identified with Site Numbers:  505029, 506745, 522087, 533824, 536622, 541547, 541556, 541557, 541558, 542423, 542426, 542427, 542584, 542684, 542769, 542854, 543059, 543219, 543220, 543222, 543458, 543459, 543460, 543461, 543462, 543463, 543464, 543465, 543862, 543947, 544191, 544396, 544411, 544456, 544457, 544458, 544459, 544460, 544461, 544462, 544463, 544464, 544465, 544466, 544467, 544469, 544470, 544471, 544473, 544474, 544475, 544476, 544533, 544562, 544622, 544972, 544984, 545085, 545102, 545103, 545139, 545140, 545284, 545397, 545492, 545631, 545751, 545822, 545922, 545924, 545961, 545996, 546086, 546145, 546461, 546508, 546516, 546531, 546579, 546680, 546687, 546786, 546788, 546851, 546999, 547000, 547082, 547169, 547171, 547172, 547221, 547284, 547288, 547299, 547375, 547602, 547603, 547643, 547656, 547684, 547710, 547746, 547790, 547791, 547805, 547839, 547975, 548004, 548104, 548308, 548354, 548366, 548385, 548397, 548398, 548569, 548602, 548653, 548700, 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  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution: Throughout the US.
  • 제품 설명
    Philips BV Pulsera Mobile X-Ray system with the extended rotation option.
  • 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