It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed
Reason for recall: It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed Distribution: Worldwide distribution - US Nationwide and the country of Dominican Republic. Quantity: 332 units Lot/code info: serial numbers: B2A1522117, E0514103, B2A15X2238, B2A1792589, A2A2242418, A2A21X2345, B2A1692413, A2A2152263, A2A2262450, A2A22Z2576, W4A1252250, A2A20Z2167, W4A10X2001, A2A2412831, W1C0552181, W1D0842501, W4D13Z2452, W4A1322350, W4D1422467, B2A1472002, A1C1982123, W2A1062134, W1B08X2042, W2A1072139, W4A1242220, A2A2382741, B2A17Z2627, A2A2152264, W4C1362387, W4D1422465, D4W1262257, W1D0892543, W4D1462478, W4A1182118, W4A11X2133, W4A11Z2167, N/A Deinstalled, A1B18Z7003, W4A1252243, DFP800A-0001, A3552017, W2A1092165, W1D0882537, A2A2122203, W4A10Z2022, W4B1332361, A2A23Y2788, W4A12Z2328, B2A1662374, W4A12Z2329, B2A1622309, B2A14X2056, A2A2272459, A2A2172291, W4A1132061, W1D0832488, W1D0882536, W2A0962022, W2A0982038, W2A0972026, B2A1642351, A2A2152255, W1D0752392, A2A2182308, A2A2412836, A2A2112189, A2A21X2336, A1C19Y2164, A1C1942056, A2A2192328, A2A2332643, W4C1372398, A2A22Y2553, A2A2132226, W4A1262256, B2A1472013, W2A1022097, W2A1022094, W4A10Z2017, W1B08Y2055, B2A1492051, B2A1492052, W4A10Z2021, W4A12Z2332, W4D1412463, W4A1122040, B2B1862727, B2B1812651, B2A1662376, B2A16X2448, B2A1742547, W4A1242230, W4A1272271, G3514035, B2A17X2601, W1D07Z2454, W4A1272272, A2A2142238, B2B1862746, B2B18X2800, A2A2022014, A2A2032029, A2A2172288, A2A2122199, A2A2152258, A2A2012004, W4A10X2004, B2B18X2810, B2B1952847, A2A2142244, A2A2172297, W2A0992045, W4A1262253, W4A1282278, W4A12Z2330, W4A1312340, W2A09Z2075, B2A1652363, W4A1272266, W4A1162079, A2A2152253, W2A1092160, W4D1452476, W1D07Y2
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.