Device Recall GE OEC 9800 Fluoroscopic xray system

  • 모델명 / 제조번호(시리얼번호)
    Serial numbers: 82-3928, 82-3929, 82-3930, 82-3931, 82-3933, 82-3934, 82-3935, 82-3936, 82-3937, 82-3938, 82-3939, 82-3941, 82-3942, 82-3943, 82-7191-MH, 82-7197-MH, 82-7206-MH, 89-3490, 89-3494, 89-3495, 89-3499, 89-3501, 89-3504, 89-3508, 89-3509, 89-3511, 89-3512, 89-3513, 89-3514, 89-3515, 89-3520, 89-3522, 89-3524, 89-3529, 89-3530, 89-3533, 89-3538, 89-3543, 89-3544, 89-3545, 89-3546, 89-3548, 89-3549, 89-3552, 89-3553, 89-3554, 89-3555, 89-3557, 89-3558, 89-3559, 89-3560, 89-3561, 89-3562, 89-3565, 89-3567, 89-3568, 89-3569, 89-3570, 89-3571, 89-3572, 89-3573, 89-3574, 89-3578, 89-3579, 8S-3183, 8S-3200, 8S-3205, 8S-3207, 8S-3211-CH, 8S-3216, 8S-3222, 8S-3231, 8S-3243, 8S-3245, 8S-3246, 8S-3247, 8S-3248, 8S-3249, 8S-3253, 8S-3254, 8S-3255, 8S-3256-H, 8S-3257, 8S-3258-CH, 8S-3259, 8S-3260, 8S-3261, 8S-3262, 8S-3263, 8S-3264, 8S-3265, 8S-3266, 8S-3267, 8S-3268, 8S-3269-H, 8S-3270-H, 8S-3271-H, 8S-3272-H, 8S-3273-CH, 8S-3274-CH, 8S-3276, 8S-3279, 8S-3280, 8S-3281, 8S-3283, 8S-3285, 8S-3286, 8S-3287, 8S-3288-H, 8S-3289-H, 8S-3290, 8S-3291, 8S-3292, 8S-3294, 8S-3295, 8S-3296, 8S-3297, 8S-3301-H, 8S-3302, 8S-3305, 8S-3306, 8S-3307, 8S-3308, 8S-3309, 8S-3310-H, 8S-3311, 8S-3315, 8S-7230-CMH, 8S-7231-MH, 8S-7232-MH, 8S-7233-MH,
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: USA including states of FL, GA, PA. CO, MD, VA and WA. and countries of Australia, Austria, Belgium, Brazil, Canada, Colombia, Finland, France, Germany, Hong Kong, India, Israel, Italy, Japan, Korea, Netherlands, New Zealand, Norway, Portugal, Switzerland, Taiwan, and the UK.
  • 제품 설명
    GE OEC 9800 Fluoroscopic X-ray System, GE Healthcare, Salt Lake City, Utah.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    GE OEC Medical Systems, Inc, 384 Wright Brothers Dr, Salt Lake City UT 84116-2862
  • Source
    USFDA