Events

Recall of Model CAT850B Catheterization Table

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Toshiba American Medical Systems Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    60229
  • Event Risk Class
    Class 2
  • Event Number
    Z-0331-2012
  • Event Initiated Date
    2011-10-03
  • Event Date Posted
    2011-12-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-03-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104829
  • Notes / Alerts
    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.
  • Extra notes in the data
    Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
  • Reason
    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.
  • Action
    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
  • Model / 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.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    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
  • Manufacturer Address
    Toshiba American Medical Systems Inc, 2441 Michelle Dr, P.O. Box 2068, Tustin CA 92781-2068
  • Manufacturer Parent Company (2017)
    Canon Inc
  • Source
    USFDA