Z-1176-2026 Class II Ongoing

Recalled by Canon Medical System, USA, INC. — Tustin, CA

Recall Details

Product Type
Devices
Report Date
February 4, 2026
Initiation Date
December 19, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
172 units

Product Description

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

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 Pattern

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

Code Information

serial numbers: W1C0632284, W4A1282279, W4A12Z2324, A2A2222381, A2A2392756, A3517001, A2A2352683, A2A2072087, A2A2072077, C1C2422647, W2A09Y2061, W2A10X2168, W4A11Y2144, A2A2232406, A2A2032038, W1D07Z2458, W2A09X2053, B2B1812645, A1C19Z2182, W4B1332362, B2A1622324, W4C1352385, W4A1292284, A1C19X2152, A1C1942058, A1C1972104, B2A1592233, B2A1792598, W2A1012081, W2A1052121, W4C1342374, B2B1872766, A4562105, W2A0972027, A1C2052199, A2A21X2339, W2A1012082, W4C1342369, W1D07Z2449, A1C1942065, A2A2132228, A2A2172285, A2A2117001, W1D06Z2357, A2A2282477, A2A2232405, W1B08X2034, A2A2182313, W4A1232210, A2A2262452, B2A16X2449, B2B1862743, B2B1872751, W1D0697014, W1C05X2229, B2A1542162, A2A21Z2364, A2A2392751, B2A1722527, A2A22Z2566, B4582115, W4C1372400, A2A2362690, A2A2252436, A2A2292510, B2A1582209, B2A1472014, W1D0732376, A2A2252439, W1D0732374, A1C1972105, A1C1972112, B4602126, W1B08Z2063, A2A2152265, A2A2132230, A2A2282491, A2A2262445, A2A22Y2550, A2A22X2528, W4A1212180, W4A1212176, W4A1212177, A1C1992141, W4A1182110, W4A11Z2163, W1D0812466, B2B18Y2816, B2B1832693, A1C1952078, A2A2062070, W2A09Z2077, A1C19Y2174, W1D0722372, A2A22X2518, A3542008, B2A1472020, W4A1242224, W4A1312348, A2A2172280, W4D1422466, W4A1142069, A2A2172287, A2A2342657, A2A2432872, B2A1552176, B2B1812657, B2B1872765, W4A1342373, B2A1682407, W4A11Z2170, W4C1342364, W4C1342365, W4A1172092, A2A2172281, W2A1072143, W4A1292281, A2A2242426, A2A2392761, A3612061, A1A2162240, A2A23Z2814, B2B1872760, A2A2262456, A1C2042197, B2A14Z2085, W4C1352377, W4A1252245, A1C19Z2178, A2A2292499, W4A1242221, W1D0872524, A1C19Z2188, A1C19X2158, A2A2052053, B2B1862731, B2A1752550, B2B1832678, B2B1852708, B2B1852710, B2B1852707, W1C0582207, W1C05Y2242, W1D0722370, W4A1272267, W2A1062127, B2A1742539, B2B1922842, A2A2062066, B2A16Y2469, W4A1122048, B2A1662369, W4A1122039, B5512160, A2A2122205, B2B1822664, B2B1822670, A2A2292498, W4D13Y2442, A2A2122197, A2A2192330, A2A2132216, A2A22X2522, A2A2432885, A2A2422855, W2A1012091, W1C05X2224, B2A1622310, A1C1972111, B2B1892787, A1C1952080, A1B18Y7002.