Device Recall Desktop Pro 4.2, 5.0, 5.1, 6.0, 6.2

  • 모델명 / 제조번호(시리얼번호)
    134615, 134621, 134091, 136364, 134172, 136285, 134605, 134183, 136167, 136234, 134259, 134115, 134081, 136047, 136063, 134701, 134328, 134391, 134432, 134436, 134438, 136119, 134535, 134561, 134475, 134564, 134154, 134269, 134348, 134399, 136084, 136087, 136100, 134200, 134118, 134822, 134018, 136368, 134241, 134606, 134711, 134473, 134787, 134768, 134571, 134237, 134104, 136009, 134331, 134272, 136322, 136175, 136200, 134503, 136257, 134322, 134781, 134380, 134709, 136108, 134250, 134254, 134258, 134206, 134195, 134094, 134652, 134704, 136107, 134469, 134472, 134483, 134519, 134729, 136109, 134236, 134239, 134197, 134456, 134047, 134092, 134211, 136373, 134275, 134679, 136106, 136163, 134667, 136181, 134169, 134329, 134126, 134090, 134358, 134427, 134626, 134819, 134027, 134265, 134597, 136319, 134220, 134256, 134396, 134804, 134235, 136338, 134137, 134234, 134249, 136034, 136065, 136110, 136267, 136291, 134213, 134219, 136330, 134750, 136097, 136270, 134457, 134078, 134129, 136195, 134375, 134603, 136074, 134075, 134565, 134196, 134428, 134430, 134008, 134382, 134070, 134157, 134772, 136080, 134860, 134401, 134368, 134388, 134631, 134318, 136015, 136096, 134563, 136165, 136240, 134441, 134017, 134048, 134189, 134395, 134324, 134595, 134140, 134212, 136086, 134354, 136178, 136317, 136318, 134445, 136012, 136332, 134321, 136071, 136089, 136292, 136293, 134673, 134685, 136059, 136169, 134073, 134748, 134754, 134378, 134383, 134458, 134192, 134499, 136069, 136092, 134642, 134295, 134671, 136046, 136147, 134062, 136049, 136036, 136152, 136157, 136083, 136081, 134770, 136118, 136156, 136172, 134352, 134548, 134533, 136153, 136269, 136197, 136252, 136286, 136315, 136241, 134811, 134812, 136258, 136312, 134069, 136310, 134864, 134040, 134046, 134307
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA including Puerto Rico and countries including: Canada and Mexico.
  • 제품 설명
    Desktop Pro 4.2, 5.0, 5.1, 6.0, 6.2 || A user interface of rthe SL/SLi Series Linear Accelerators that are used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Elekta, Inc., 4775 Peachtree Industrial Blvd, Bldg 300, #300, Norcross GA 30092-3011
  • 제조사 모회사 (2017)
  • Source
    USFDA