Canon Medical System, USA, INC.: Alphenix INFX-8000V, interventional fluoroscopic x-ray system

Company / brand

Canon Medical System, USA, INC.

Product

Alphenix INFX-8000V, interventional fluoroscopic x-ray system

Reason / hazard

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

Classification

Class II

Status

Ongoing

Distribution / sold at

Worldwide distribution - US Nationwide and the country of Dominican Republic.

Recall initiated

2025-12-19

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, W1D07Y2445, W2A1072147, A1C1962090, A1C1962089, B2A1652362, W4D14Y2481, A2A20Z2157, A2A22Y2547, A2A2162266, W4A1212183, W4A1212189, W4A1212190, W4A11Z2172, W4A1212178, W4A1212191, W4A1212185, W4A1212184, W4A1132060, W4A1242222, B2A1612295, B2A16Y2468, W4A1222003, A4512077, W2A0982043, W1D0892547, W2A0972030, W2A1042109, A2A2322602, W2A1047001, A1C1982121, A2A2332647, B2A16Y2455, B2A16Y2456, B2A17X2608, B2A17X2605, B2A17X2607, B2A1592231, A2A2232398, B2B1822666, W1B08Z2064, W1B08Z2067, A1C1942063, A1B1922042, B2B1842698, B2B1882777, B2B1892792, W4A1162083, A1C1962094, W4A1222202, W4A12X2299, B2A15X2243, A2A20Y2153, W2A1072141, W4A10Z2014, W4A1142064, W4A1252239, W2A1062136, A2A21X2344, W1D0697017, A2A2022026, A2A22Z2572, W1D0882538, A2A2142237, A2A20Z2161, A1C1992148, W4A1252241, B2A16X2454, W4A1242223, W4A1162089, A2A2242410, B2A1622320, W1D0812470, A2A2182307, A2A2332638, W4A1272240, B2A16Y2474, A2A2262444, A1C1952074, B2A1612300, W4A10Y2006, B2A1582203, W4A1242231, W4A12X2300, B2A1522121, B2A1532152, A2A2142245, B2A1512107, W4D1452473, A1C1992135, A2A2132229, A2A2092109, A2A2052055, A2A2142241, W2A09Y2065, A2A2062064, A2A21X2347, W4C1382414, B2A16Z2492, B2B1582210, B2A14X2062, B2A14Z2097, B2B1882769, W2A0962024, W4A1272261, W2A1052126, W2A09Y2064, B2A1622321, W4A10Z2018, W4A1262254, W4A1182121, W4C13X2433, W4C13X2432, W4C1372401, W1C0632285, A2A2282476, W4C1362389, W4A1322353, B2A15Y2252, W2A1042114, W2A1052125, W2A1072142, W4A1312343, W4A1142063, W4C1362388, W4C1352376, W4C1352378, B2B1862733, A1C1962097, B2B2032825, B2A1592224, A1C1962088, W1B08X2026, W1D0872529, W1D0732379, B2B1872763, B2A17Z2630, B2A17Z2629, W4A11X2132, W4A1112033, F1514114, W4A1122043, W4A1242237, W1D0697015, W1B08X2036, A2A2132227, W1B08Y2050, W4A1112035, W2A09Z2078, A2A2292515, A2A2422852, B2A1582215, W4A1272262, A1C1942064, W4C1342371, A1C19X2155, W4A1212186, W4A1212175, A2A2072088, B2A16Y2467, B2A1612293, B2B18Z2830, B2B1812654, W4A11Z2169, W4A1222196, W4A1212174, W1D0862519, W4A1217002, W4A1242225, B2A14X2057, A2A2432873, W1D0892545, A2A2232396, A2A2382740, W4D1452474, B2A17Z2634, B2B1842701, W2A1072145, F9624025, B2A1532147, A2A2262447, A2A2142246, B2A14Z2099, A2A2152262, B2B1832680, A2A2242429, W1D0782416, B2B1862728, B2B1862735, B2A1642352, B2A16Z2480, W4A1312344, A2A2082098, W2A0982041, B2A1772578, A2A2092106, W4A1162085, B2B1832692, A2A2142236, B2A1552177, A1B1932051, A1B1932049, B2A1682401, W4A12Z2323, B2A1712502, B2A17X2604, W4A12Y2316, B2A1712504, B2A1512106, A2A20X2083.

Product quantity

332 units

Voluntary mandated

Voluntary: Firm initiated

City

Tustin

State

CA

Country

United States

Event id

97970

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