Events

Device Recall Philips Healthcare Brilliance 16 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Philips Medical Systems (Cleveland) 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
    74820
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2655-2016
  • 사례 시작날짜
    2016-07-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-07-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148521
  • 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, tomography, computed - Product Code JAK
  • 원인
    After upgrading to 3.6.7 software version via fco72800643, during reconstruction of gated helical scans, the planned anatomy can be cut off on the ct images. this issue can occur on gated ct helical reconstruction that is not planned at iso-center (0,0). if the region of interest is not visualized in the images, a ct rescan may be performed.
  • 조치
    Customers were sent a letter dated July 28, 2016 informing them of the problem, under what circumstances it can occur and the actions that the customer can take to minimize the effect of the problem. The letter also includes the actions planned by Philips to correct the problem. Philips plans on releasing a field change order (FCO) to correct the affected systems. If you need any further information or support concerning this issue, contact your local Philips representative or local Philips Healthcare office. For North America and Canada, contact the Customer Care Solutions Center (1 -800-722-9377).

Device

Device Recall Philips Healthcare Brilliance 16
  • 모델명 / 제조번호(시리얼번호)
    728246 -- Brilliance 16  3010 3017 3031 3040 3043 3070 3072 3085 3090 3117 3149 3216 3247 3293 3314 5006 5012 5018 5020 5024 5026 5028 5030 5031 5035 5044 5045 5052 5053 5054 5055 5058 5059 5060 5064 5069 5070 5081 5086 5088 5091 5093 5097 5099 5103 5107 5108 5110 5111 5115 5116 5118 5120 5123 5126 5127 5128 5131 5138 5140 5155 5160 5161 5163 5166 5184 5186 5188 5190 5191 5192 5193 5195 5197 5208 5209 5216 5219 5235 5236 5238A 5270 5272 5279 5282 5285 5287 5294 5295 5315 5316 5350 5354 5357 5360 5368 5394 5433 5434 5443 5453 5457 5480 5487 5501 5502 5505 5519 5523 5526 5554 5572 5573 5576 5609 5615 5633 5647 5653 5683 5723 5758 5762 5764 5771 5811 5897 5929 5937 5956 5974 5995 6021 6022 6031 6033 6048 6053 6072 6220 6229 6243 6280 6283 6298 6309 6321 6360 6375 6405 6426 6441 6465 6474 6484 6503 6511 6517 6519 6523 6549 6559 30049 32287 50011 50053 50087 50180 3123 5674 6555 32366 3465 50181 5135 5237 3179 3411 5009 5048 5077 5412 6154 30011 30110 5101 5181 3324 5405 3050 3441 6387
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution in the states of: AL,AR,AZ,CA,CO,CT,DC,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA, MD,ME,MI,MN,MO,MS,NC,ND,NE,NJ,NM, NV,NY,OH,OK,OR,PA,PR,SC,TN,TX,UT,VA,VT,WA,WI,WV,WY
  • 제품 설명
    Brilliance 16, Model number 728246 || Product Usage: || Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc

Manufacturer

Philips Medical Systems (Cleveland) Inc
  • 제조사 주소
    Philips Medical Systems (Cleveland) Inc, 595 Miner Rd, Cleveland OH 44143-2131
  • 제조사 모회사 (2017)
    Philips
  • Source
    USFDA