| Class 2 Device Recall Imageintensified fluoroscopic xray system, mobile | |
Date Initiated by Firm | May 15, 2023 |
Date Posted | July 31, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-2277-2023 |
Recall Event ID |
92504 |
510(K)Number | K073543 K082781 K120613 K122234 |
Product Classification |
Image-intensified fluoroscopic x-ray system, mobile - Product Code OXO
|
Product | OEC 9900 Systems with 9-inch Image Intensifier |
Code Information |
UDI-DI: 00840682114301
Serial Numbers: ES-2700, ESXXXL00081, ESXXXL00104, ES-2873, ESXXXX04525, ESXXXX04526, ESXXXX04527, E9-2573, E9XXXX03024, ESXXXX04467, ES-2768, ESXXXX03911, ESXXXX04425, E9-2510, E9-2646, ES-3208, ES-3209, ES-2934, ES-2940, ESXXXX04391, ES-0662, ES-3216, ES-3217, E9-1266, E9-2330, ESXXXX04441, E9XXXX03364, ES-1631, ES-2835, ES-2846, ES-2987, ES-3179, ESXXXX04377, ES-2692, ES-2693, ES-2847, ES-2679, E9-1695, E9-1716, E9-1719, E9-2183, E9-2186, E9-2327, E9-2328, E9-2451, E9-2517, ES-3110, ESXXXX04365, ESXXXX04369, E9-2286, E9-2571, ESXXXX04472, ES-2647, ESXXXX04436, E9-2189, ES-2755, ESXXXX04475, E9-2645, ESXXXX04449, ES-2667, ESXXXX04435, E9XXXX03408, E9-2187, ES-2868, ESXXXX04394, ES-2981, ES-2942, ES-2965, ESXXXX04505, E9-2246, ES-2988, E9XXXX03336, ES-1548, ES-2948, ESXXXX04462, E9-0975, ES-3080, ESXXXX04061, ESXXXX04497, ESXXXX04465, ESXXXX04468, ESXXXX04489, E9-2562, ES-2953, ESXXXX04464, ESXXXX04488, ESXXXX04484, ES-2808, ES-2689, ES-2848, ES-2995, ESXXXL00057, ES-2849, ES-3090, 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E9-2256, E9-2582, ESXXXL00085, ESXXXX04508, E9-2579, ES-2996, E9-2594, ES-2683, ES-2858, E9-2899, ES-2756, ES-2774, ES-2937, ES-2761, ES-2867, ES-2694, ES-2655, ES-3063, ES-2964, ESXXXL00056, ES-2892, ES-2680, ES-3058, ES-3297, E9-2516, E9-2520, ES-2890, ES-2629, ESXXXX04514, ES-3152, ES-3153, ESXXXX04407, ESXXXX04427, ES-2649, ES-2773, ES-2776, ES-3255, ESXXXX04458, ESXXXX04470, E9-2190, ES-2668, ES-3745, E9-2285, E9-2566, ESXXXX04338, E9-2206, E9XXXX03425, ES-2659, E9-2565, ES-2866, ES-2869, E9-2201, E9-2202, E9-2499, E9XXXX03433, E9-2580, ESXXXL00069, E9-2203, E9-2204, ES-2686, ESXXXL00073, ES-2946, E9-2390, E9-2643, E9-2556, E9-2395, E9-2572, ES-3079, ES-3081, E9-2638, ESXXXX04485, E9-2679, ES-3300, ESXXXX04366, E9-2211, E9-2284, E9-2304, E9-2346, E9-2407, E9-2511, E9-2512, E9-2569, E9XXXX03485, ES-0080, ES-2652, ES-2954, ES-2997, ES-3598, ES-2775, E9-2831, ESXXXX04451, ES-2666, ES-2915, ES-3341, ES-3056, ES-1052, E9-2404, ES-2650, ES-3112, ES-3301, ESXXXX04453, ES-2665, E9-2398, E9-2399, E9-2318, E9-2392, ES-2691, ES-3204, ESXXXL00075, ESXXXL00076, ESXXXX04439, E9-2532, ES-2635, ES-3180, ES-2914, ES-2952, ESXXXX04509, ES-2787, ESXXXL00061, E9-2298, E9-2200, E9-2557, E9-2889, ES-2825, ES-2907, ES-3135, ES-3136, ES-3137, ESXXXX04501, E9-2245, E9-2297, ES-2754, E9-2296, E9-2523, ESXXXX04521, ES-3134, ES-2660, ESXXXX04448, ES-2994, ESXXXX04482, ESXXXX04443, E9-2329, E9-2397, E9-2401, E9-2640, E9-2642, E9-2652, E9XXXX03419, E9XXXX03493, ES-2648, ES-2687, ES-2772, ES-2834, ES-2909, ES-2972, ES-3074, ES-3215, ES-7307-CMH, ESXXXX04481, ESXXXX04492, ES-2685, ESXXXX04463, E9-2210, E9-2567, ES-3193, ES-3203, ES-3167, ESXXXL00087, ES-2810, E9XXXX03365, ES-2637, ES-2893, ES-3040, E9-2639, ES-2856, E9-2393, E9-2345, ESXXXL00089, E9XXXX03437, ESXXXX04516, ES-2970, E9-2185, E9XXXX03436, E9-2521, ES-2889, ESXXXX04370, ESXXXX04490, E9-2654, E9-2496, ES-2999, ES-3285, E9-2588, ES-2682, ES-2979, ES-2630, ES-2991, E9-2568, E9-2205, ES-3083, E9-2551, E9-2833, E9-2835, ES-3085, 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|
Recalling Firm/ Manufacturer |
GE OEC Medical Systems, Inc 384 N Wright Brothers Dr Salt Lake City UT 84116-2862
|
For Additional Information Contact | 801-536-4811 |
Manufacturer Reason for Recall | Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved, which may result in the image intensifier falling, which could lead to injuries such as fractures, hematoma, contusion, bruise, pain. |
FDA Determined Cause 2 | Process control |
Action | On 5/15/23 correction notices were mailed to: Director/Manager of Radiology, Hospital Administrator, Head of Radiology Department, PACS Administrator, Director of IT Department, Head, Biomedical Engineering, who were asked to do the following:
You can continue to use your device. When transporting the device, ensure it is always
in the Anterior Posterior (AP) position, as instructed in the systems Operator Manual.
Use caution when moving system to avoid a large impact force.
In addition, customers were asked to complete and return the acknowledgement response form to fieldactionssurgery@ge.com
Customers with questions or concerns can contact the firm at 1-800-437-1171 |
Quantity in Commerce | 908 |
Distribution | Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and the countries of Algeria, Argentina, Australia, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Burkina Faso, Canada, Chile, Colombia, Czechia, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, France, Georgia, Germany, Hong Kong, India, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Kazakhstan, KOREA, Malaysia, Mauritius, Mexico, Mongolia, Morocco, Nepal, New Caledonia, New Zealand, Nigeria, Paraguay, Peru, Poland, Portugal, Romania, Russia, Singapore, Spain, Switzerland, Taiwan, Tanzania, Thailand, Trinidad and Tobago, United Arab Emirates, United Kingdom, Uruguay, Vietnam. |
Total Product Life Cycle | TPLC Device Report |
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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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = OXO 510(K)s with Product Code = OXO 510(K)s with Product Code = OXO
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