GE OEC Medical Systems, Inc


   04 رجب 1428 هـ الموافق 18 يوليو 2007 م
Recalling Firm / Manufacturer GE OEC Medical Systems, Inc
Product GE OEC 9800 Fluoroscopic X-ray System, GE Healthcare, Salt Lake City, Utah.
Code Information 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,
Reason of Recall X-ray systems were not configured to display Air Kerma Rate and Cumulative Air Kerma.
Date Recall Initiated June 12, 2007
Action Consignees were notified by letter on 06/12/2007 and told that a service representative would arrange for an inspection and would modify their systems. Firm Initiated recall is ongoing.
Contact GE Healthcare
01 / 4600530
Source of Information U.S. FDA
SFDA Comments SFDA urges all hospitals that have devices subjected to recall, to contact the company.