GE OEC Medical Systems, Inc


   04 رجب 1428 هـ الموافق 18 يوليو 2007 م
Recalling Firm / Manufacturer GE OEC Medical Systems, Inc
Product GE OEC 6800 Fluoroscopic X-ray System, GE Healthcare, Salt Lake City, Utah.
Code Information Serial numbers: 86-2102, 86-2133, 86-2137, 86-2138, 86-2139, 86-2140, 86-2143, 86-2145, 86-2146, 86-2147, 86-2148, 86-2149, 86-2150, 86-2151, 86-2152, 86-2153, 86-2154, 86-2155, 86-2156, 86-2157, 86-2158, 86-2159, 86-2160, 86-2161, 86-2162, 86-2163, 86-2164, 86-2165, 86-2166, 86-2167, 86-2168, 86-2169, 86-2170, 86-2171, 86-2172, 86-2173, 86-2174, 86-2175, 86-2176, 86-2177, 86-2178, 86-2179, 86-2180, 86-2181, 86-2182, 86-2183, 86-2184, 86-2185, 86-2186, 86-2187, 86-2188, 86-2189, 86-2190, 86-2191, 86-2192, 86-2193, 86-2194, 86-2195, 86-2196, 86-2197, 86-2198, 86-2199, 86-2200, 86-2201, 86-2202, 86-2203, 86-2204, 86-2205, 86-2206, 86-2207, 86-2208, 86-2209, 86-2210, 86-2211, 86-2212, 86-2213, 86-2214, 86-2215, 86-2216, 86-2217, 86-2218, 86-2219, 86-2220, 86-2221, 86-2222, 86-2223, 86-2224, 86-2225, 86-2226, 86-2227, 86-2228, 86-2229, 86-2230, 86-2231, 86-2232, 86-2233, 86-2234, 86-2235, 86-2236, 86-2237, 86-2238, 86-2239
Reason of Recall X-ray systems were not configured to display Air Kerma Rate and Cumulative Air Kerma.
Date Recall Initiated June 12, 2007
Action Consignees were notified by letter on 06/12/2007 and told that a service representative would arrange for an inspection and would modify their systems. Firm Initiated recall is ongoing.
Contact GE Healthcare
01 / 4600530
Source of Information U.S. FDA
SFDA Comments SFDA urges all hospitals that have devices subjected to recall, to contact the company.