Events

Recall of Device Recall Toshiba DUA450F Kalare 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
    56415
  • Event Risk Class
    Class 2
  • Event Number
    Z-1675-2011
  • Event Initiated Date
    2010-07-15
  • Event Date Posted
    2011-03-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93589
  • 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
    Radiographic Tilting Table - Product Code IXR
  • Reason
    Top table lateral movement on their dua-450f kalare table cannot be performed, or the table top lateral movement is performed at an extremely low speed. as a result, positioning of the patient cannot be performed by tabletop movement.
  • Action
    Toshiba America Medical Systems (TAMS) issued Urgent Medical Device Correction notification dated July 8, 2010, to consignees via USPS return receipt mail. The letter contains a return reply form that is to be faxed to TAMS as proof of notification.

Device

Device Recall Toshiba DUA450F Kalare Table
  • Model / Serial
    Last 4 of serial number: 2033, 2034, 2036, 2037, 2038, 2039, 2040, 2041, 2043, 2044, 2045, 2046, 2047, 2048, 2050, 2051, 2052, 2053, 2056, 2059, 2060, 2061, 2062, 2063, 2064, 2065, 2066, 2067, 2068, 2069, 2070, 2071, 2072, 2073, 2075, 2076, 2077, 2080, 2081, 2082, 2083, 2084, 2085, 2086, 2087, 2088, 2089, 2090, 2091, 2092, 2093, 2095, 2096, 2098, 2099, 2100, 2107, 2108, 2109, 2111, 2112, 2113, 2114, 2115, 2116, 2117, 2118, 2120, 2121, 2123, 2124, 2125, 2126, 2127, 2129, 2130, 2131, 2132, 2133, 2134, 2135, 2136, 2137, 2138, 2140, 2141, 2142, 2144, 2145, 2146, 2147, 2148, 2149, 2152, 2153, 2154, 2155, 2157, 2160, 2161, 2162, 2165, 2166, 2168, 2169, 2170, 2171, 2173, 2175, 2176, 2177, 2178, 2179, 2180, 2181, 2182, 2183, 2185, 2186, 2187, 2188, 2189, 2190, 2192, 2193, 2194, 2195, 2196, 2198, 2199, 2200, 2201, 2203, 2204, 2205, 2206, 2208, 2209, 2210, 2211, 2212, 2214, 2215, 2216, 2217, 2218, 2219, 2220, 2221, 2222, 2223, 2224, 2226, 2227, 2228, 2229, 2232, 2233, 2234, 2236, 2237, 2238, 2239, 2240, 2241, 2243, 2244, 2245, 2246, 2247, 2249, 2250, 2252, 2253, 2254, 2255, 2257, 2258, 2259, 2260, 2261, 2262, 2263, 2264, 2265, 2266, 2267, 2268, 2269, 2270, 2271, 2272, 2273, 2274, 2275, 2276, 2277, 2278, 2279, 2280, 2281, 2282, 2284, 2285, 2287, 2292, 2295, 2296, 2297, 2001, 2002, 2003, 2004, 2005, 2007, 2008, 2009, 2010, 2011, 2012, 2013, 2014, 2015, 2016, 2018, 2019, 2020, 2021, 2022, 2023, 2024, 2025, 2026, 2027, 2028, 2029, 2030, 2031, 2156, 2213, 2283, 2288, 2289, 2290, 2293, 2294, 2298, 2299, 2300, 2301, 2242, 2139, 2302, 2303, 2304
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide
  • Product Description
    Toshiba DUA-450F Kalare Radiographic Tilting Table.
  • 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