Events

Device Recall SOMATOM Definition Flash 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Siemens Medical Solutions USA, 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
    79295
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1747-2018
  • 사례 시작날짜
    2017-11-08
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164182
  • 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
    Computed tomography x-ray diagnostic system - Product Code JAK
  • 원인
    There is a potential risk of unnecessary radiation exposure due to a software issue found in the care dose4d algorithm implemented in siemens healthineers ct scanners of types somatom definition as, somatom definition ds, somatom definition edge, somatom definition flash and somatom force.
  • 조치
    Siemens Medical Solutions USA, Inc. will bring defect into Compliance noted below: 1.You will contact customers and initiate the actions to correct the failure to comply issue. 2. You will provide a software update to correct tube current calculations by the CARE Dose4D algorithm for head scans. 3.You will follow-up with consignees to verify the effectiveness of the software update. CDRH approves the CAP subject to the following conditions: 1.Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) division office coordinator noted below are to be included. For further questions, please call (610) 448-6471.

Device

Device Recall SOMATOM Definition Flash
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: 73917 73064 98602 98603 73476 73339 73739 73059 73586 73421 73937 98616 73312 74206 73075 73099 73544 73648 74156 73734 73343 73374 73726 73526 73636 73346 73518 74207 73258 74054 73860 73579 73813 73930 73120 73108 74360 73054 74128 74926 73679 73427 98600 73622 73533 73621 73423 73424 73493 73520 73718 73459 73372 73637 73303 73296 73349 74924 74927 73786 73240 73279 73278 74374 73531 73760 73831 73224 73820 74042 73840 74191 73832 73152 74117 74118 74405 73673 73651 73352 73044 74456 73487 73492 73494 73497 73016 73711 74929 73310 73409 73778 73935 73642 73709 73722 74240 73130 73013 73657 73300 73499 73535 73090 98607 73377 73031 73355 73777 98617 73330 73883 73366 73783 73036 73623 73908 74978 73667 73285 73281 73141 73684 73248 74391 74209 73490 74399 73461 73428 73791 73455 73191 73887 73071 98606 74094 98601 74098 74045 74363 73758 73513 74368 73368 73035 73895 73297 73182 73122 74262 74116 73253 73337 73375 74158 74153 73153 73545 74192 98613 74925 73670 73361 74226 74297 74234 74364 74376 73162 73262 73328 73241 73683 74048 74068 73320 73697 73635 73405 73471 74912 73160 73600 73742 73030 73655 73931 73921 73818 73873 73028 74145 73155 73591 74904 73905 73938 98605 73244 73546 74922 73478 73547 73442 73886 73504 73413 73674 73514 73464 73445 74129 73538 73420 73904 74093 73127 73185 73268 73761 74200 74289 74062 73521 73522 73261 73357 73430 74251 73235 73911 73574 73061 73604 74152 73151 73225
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed in all 50 U.S. states, the District of Columbia, Guam, and Puerto Rico.
  • 제품 설명
    SOMATOM Definition Flash (Model 10430603) Computed tomography x-ray diagnostic system
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • 제조사 주소
    Siemens Medical Solutions USA, Inc, 40 Liberty Blvd, Malvern PA 19355-1418
  • 제조사 모회사 (2017)
    Siemens Ag
  • Source
    USFDA