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U.S. Department of Health and Human Services

Class 2 Device Recall Toshiba DUA450F Kalare Table

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 Class 2 Recall
Toshiba DUA450F Kalare Table
see related information
Date Posted March 16, 2011
Recall Status1 Terminated on April 20, 2012
Recall Number Z-1675-2011
Recall Event ID 56415
Premarket Notification
510(K) Number
K922364 
Product Classification Table, Radiographic, Tilting - Product Code IXR
Product Toshiba DUA-450F Kalare Radiographic Tilting Table.
Code Information 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
Recalling Firm/
Manufacturer
Toshiba American Medical Systems Inc
2441 Michelle Dr
P.O. Box 2068
Tustin, California 92781-2068
Consumer Instructions Contact the recalling firm for information
Manufacturer 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.
FDA Determined
Cause 2
DESIGN: 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
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = IXR and Original Applicant = TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
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