Class 2 Device Recall GE OEC 9800 Fluoroscopic XRay System

• Date Initiated by Firm: August 12, 2008
• Date Posted: September 25, 2008
• Recall Status: Terminated on April 23, 2012
• Recall Number: Z-1884-2008
• Recall Event ID: 49486
• 510(K)Number: K024012
• Product Classification: Fluoroscopic X-Ray System - Product Code JAA
• Product: GE OEC 9800 Fluoroscopic X-Ray System, GE Healthcare, Surgery, Salt Lake City, Utah. The intended use of this device is to perform mobile fluoroscopic examination of human anatomy.
• Code Information: Serial Numbers: 82-2965, 82-3366, 82-3403, 82-3563, 82-3570, 82-3614, 82-3634, 82-3815, 82-3839, 82-3851, 82-3882, 82-3884, 82-3887, 82-3888, 82-3890, 82-3894, 82-3895, 82-3896, 82-3898, 82-3899, 82-3901, 82-3903, 82-3904, 82-3910, 82-3911, 82-3912, 82-3913, 82-3914, 82-3915, 82-3917, 82-3919, 82-3920, 82-3921, 82-3922, 82-3923, 82-3925, 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, 82-7154-CMH, 82-7189-MH, 82-7190-MH, 82-7191-MH, 82-7197-MH, 82-7200, 82-7206, 89-3211, 89-3355, 89-3420, 89-3461, 89-3479, 89-3483, 89-3488, 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, 89-3519, 89-3520, 89-3522, 89-3524, 89-3527, 89-3529, 89-3530, 89-3533, 89-3537, 89-3538, 89-3539, 89-3543, 89-3544, 89-3545, 89-3546, 89-3547, 89-89-3549, 89-3551, 89-3552, 89-3553, 89-3554, 89-3555, 89-3556, 89-3557, 89-3558, 89-3559, 89-3560, 89-3561, 89-3562, 89-3563, 89-3564, 89-3565, 89-3567, 89-3568, 89-3569, 89-3570, 89-3571, 89-3572, 89-3573, 89-3574, 89-3578, 89-3579, 8S-1474-C, 8S-2329, 8S-2462, 8S-2532, 8S-2985, 8S-3111, 8S-3112, 8S-3179, 8S-3183, 8S-3197, 8S-3205, 8S-3207, 8S-3211-CH, 8S-3216, 8S-3222, 8S-3231, 8S-3233, 8S-3243, 8S-3245, 8S-3246, 8S-3247, 8S-3248, 8S-3249, 8S-3253, 8S-3254, 8S-3255, 8S-3256, 8S-3257, 8S-3258, 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-3275, 8S-3276, 8S-3278, 8S-3279, 8S-3280, 8S-3281, 8S-3282, 8S-3283, 8S-3285, 8S-3286, 8S-3287, 8S-3288-H, 8S-3289-H, 8S-3291, 8S-3292, 8S-3296, 8S-3299, 8S-3301-H, 8S-3302, 8S-3305, 8S-3306, 8S-3307, 8S-3308, 8S-3309, 8S-3310-H, 8S-3311, 8S-3315, 8S-7094-CMH, 8S-7228-CMH, 8S-7229-CMH, 8S-7230-CMH, 8S-7231-MH, 8S-7232-MH, and 8S-7233-MH.
• Recalling Firm/ Manufacturer: OEC Medical Systems, Inc; 384 Wright Brothers Dr; Salt Lake City UT 84116-2862
• For Additional Information Contact: Deena Pease; 801-536-4952
• Manufacturer Reason for Recall: Beam limitation may be non-compliant on some X-ray units.
• FDA Determined Cause: Radiation Control for Health and Safety Act
• Action: Consignees were notified by letter on 08/12/2008. GE service representatives will check proper beam compliance on next scheduled maintenance visit or will schedule a visit to address the issue. Information available at 1-800-874-7378.
• Quantity in Commerce: 201 systems
• Distribution: Nationwide
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JAA and Original Applicant = GE OEC MEDICAL SYSTEMS