Events

Retiro De Equipo (Recall) de Model CAT850B Catheterization Table

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Toshiba American Medical Systems Inc.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    60229
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0331-2012
  • Fecha de inicio del evento
    2011-10-03
  • Fecha de publicación del evento
    2011-12-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-03-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104829
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
  • Causa
    The recall was initiated because toshiba has confirmed that during patient transfer from a gurney to the catherization table, the tabletop may rotate unexpectedly when sufficient force is applied to the tabletop. the result of the tabletop rotating unexpectedly is the patient being tranferred may fall from the tabletop.
  • Acción
    Toshiba America Medical Systems sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated October 3, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. Customers were instructed to follow the user instructions by positioning the tabletop at the foot-end position, and ensuring sufficient assistance is available, when transferring a patient from the gurney to the CAT-850B catheterization table. Customers were also instructed to follow the instructions for transferring a patient to the CAT-850B that are included in the operation manual. A Customer Reply Form was included with the letter for customers to complete and return via fax to (877) 349-3054. The customer reply form can also be sent via e-mail to raffairs@tams.com. Questions regarding the recall letter can contact the Director of Regulatory Affairs at (800) 421-1968 or contact their local Toshiba Representative at (800) 521-1968.

Device

Model CAT850B Catheterization Table
  • Modelo / Serial
    Last Four Digits of Lot #2408, 2064, 2851, 2076, 2081, 2804, 2109, 2100, 2519, 2521, 2008, 3063, 2537, 2350, 2382, 2834, 3030, 3043, 3250, 3194, 2105, 2938, 2063, 2148, 2187, 2313, 2324, 2330, 2331, 2424, 2284, 2692, 2067, 2416, 2802, 3294, 2846, 2852, 2901, 3011, 3075, 3167, 2590, 2591, 2462, 3044, 2305, 3155, 3066, 3102, 3290, 3188, 2176, 2781, 3293, 2117, 3308, 3309, 2862, 2321, 2225, 2235, 2238, 3041, 7003, 7004, 2502, 2599, 3317, 2246, 2272, 2217, 3330, 3048, 2954, 3341, 2391, 2835, 2557, 2303, 2294, 2440, 2348, 2597, 3003, 2369, 2500, 2070, 2613, 2299, 2301, 2216, 3146, 3166, 3110, 2262, 2040, 2675, 3064, 2097, 2145, 3203, 2870, 2306, 2750, 2776, 2691, 2410, 7005, 2930, 2494, 2052, 2244, 2245, 2457, 3345, 2683, 2152, 2995, 2970, 2816, 2763, 2593, 2708, 2674, 2744, 2547, 2966, 2967, 2730, 2836, 2843, 2844, 2845, 2643, 2751, 2261, 2373, 2697, 2559, 2405, 2565, 3189, 2121, 3134, 2821, 3195, 2157, 2158, 2206, 3193, 3285, 3350, 2841, 2401, 2503, 2863, 2534, 2140, 2530, 3355, 3262, 3307, 2581, 2736, 2982, 2418, 2280, 2281, 3149, 2353, 2456, 2346, 2349, 2091, 2343, 3213, 2815, 2857, 2909, 2973, 3049, 3047, 2544, 2688, 3060, 2315, 2308, 2676, 2961, 3176, 2760, 3187, 2267, 2504, 2908, 2738, 2007, 3156, 3373, 3380, 2354, 2524, 2190, 2250, 3173, 3197, 3349, 2470, 2178, 2174, 2785, 3022, 3371, 3108, 2394, 3352, 2383, 2824, 2574, 2659, 2789, 2782, 2788, 2498, 2614, 2975, 2398, 3150, 2620, 2752, 3319, 2445, 2501, 2837, 2737, 2801, 2194, 2213, 2513, 2558, 2957, 2984, 2204, 3123, 2395, 2478, 2595, 2921, 3325, 2399, 3074, 3087, 3181, 2900, 2538, 3314, 2082, 3236, 2814, 2095, 3200, 3055, 3056, 2022, 3178, 2310, 3093, 2198, 2096, 2268, 3305, 2952, 2628, 2994, 2427, 2655, 2989, 2374, 2447, 3378, 3198, 3346, 2362, 2455, 2721, 3261, 2423, 2439, 2569, 2682, 3177, 3233, 2104, 2871, 2876, 2073, 2316, 2128, 3336, 3427.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    Model CAT-850B Catheterization Table, a component of the Toshiba INFX-8000 series X-Ray Interventional System. || These systems are single or dual plane systems that employ x-rays to obtain fluoroscopy or radiography images of the body. The system is comprised of a computer system, support arms (that contain the tube and solid state detector), x-ray generator and a patient table. This device is a digital x-ray system configured for use as a diagnostic x-ray angiography system. This x-ray angiography system is used for diagnostic and interventional procedures for cardiac blood vessels, cerebral blood vessels, abdominal blood vessels and lower extremities.
  • Manufacturer
    Toshiba American Medical Systems Inc

Manufacturer

Toshiba American Medical Systems Inc
  • Dirección del fabricante
    Toshiba American Medical Systems Inc, 2441 Michelle Dr, P.O. Box 2068, Tustin CA 92781-2068
  • Empresa matriz del fabricante (2017)
    Canon Inc
  • Source
    USFDA