Z-1675-2011

Toshiba DUA-450F Kalare Radiographic Tilting Table

Name: Z-1675-2011 Toshiba DUA-450F Kalare Radiographic Tilting Table
Creator: Toshiba American Medical Systems Inc
Published: 2010-07-15
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2010-07-15 / Terminated / root cause: software

FDA source

Toshiba American Medical Systems Inc began a recall of Toshiba DUA-450F Kalare Radiographic Tilting Table on 2010-07-15. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1675-2011
Status: Terminated
Initiated: 2010-07-15
Posted: 2011-03-16
Terminated: 2012-04-20
Recalling firm: Canon Medical Systems USA, Inc.
Product: Toshiba DUA-450F Kalare Radiographic Tilting Table.
Product code: IXR Table, Radiographic, Tilting
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software design
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.
Quantity in commerce: 238 systems
Distribution: US Nationwide
Product codes and lots: 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 code IXR

K922364Class IIDua-900A Image-Intensified Fluoroscopic X-Ray SystToshiba America Medical Systems, In.C / cleared 1992-09-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)