--- title: "Alphenix INFX-8000C, interventional fluoroscopic x-ray system — FDA record Z-1176-2026 | Is It on Recall" description: "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 i" url: https://isitonrecall.com/recall/fda-device-z-1176-2026-alphenix-infx-8000c-interventional-fluoroscopic-x-ray-system/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # Alphenix INFX-8000C, interventional fluoroscopic x-ray system — FDA record Z-1176-2026 Reported ongoing Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice. Source date Dec 19, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: Alphenix INFX-8000C, interventional fluoroscopic x-ray system - **Reason**: 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 - **Recalling firm**: Canon Medical System, USA, INC. - **Quantity**: 172 units - **Agency-reported status**: Ongoing - **Source record identifier**: Z-1176-2026 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1176-2026%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | 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. | Match all identifying details in the current notice. A brand name alone is not enough. ## Distribution Worldwide distribution - US Nationwide and the country of Dominican Republic. States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address. - [Alaska](https://isitonrecall.com/state/alaska/) - [Alabama](https://isitonrecall.com/state/alabama/) - [Arkansas](https://isitonrecall.com/state/arkansas/) - [Arizona](https://isitonrecall.com/state/arizona/) - [California](https://isitonrecall.com/state/california/) - [Colorado](https://isitonrecall.com/state/colorado/) - [Connecticut](https://isitonrecall.com/state/connecticut/) - [Delaware](https://isitonrecall.com/state/delaware/) - [Florida](https://isitonrecall.com/state/florida/) - [Georgia](https://isitonrecall.com/state/georgia/) - [Hawaii](https://isitonrecall.com/state/hawaii/) - [Iowa](https://isitonrecall.com/state/iowa/) - [Idaho](https://isitonrecall.com/state/idaho/) - [Illinois](https://isitonrecall.com/state/illinois/) - [Indiana](https://isitonrecall.com/state/indiana/) - [Kansas](https://isitonrecall.com/state/kansas/) - [Kentucky](https://isitonrecall.com/state/kentucky/) - [Louisiana](https://isitonrecall.com/state/louisiana/) - [Massachusetts](https://isitonrecall.com/state/massachusetts/) - [Maryland](https://isitonrecall.com/state/maryland/) - [Maine](https://isitonrecall.com/state/maine/) - [Michigan](https://isitonrecall.com/state/michigan/) - [Minnesota](https://isitonrecall.com/state/minnesota/) - [Missouri](https://isitonrecall.com/state/missouri/) - [Mississippi](https://isitonrecall.com/state/mississippi/) - [Montana](https://isitonrecall.com/state/montana/) - [North Carolina](https://isitonrecall.com/state/north-carolina/) - [North Dakota](https://isitonrecall.com/state/north-dakota/) - [Nebraska](https://isitonrecall.com/state/nebraska/) - [New Hampshire](https://isitonrecall.com/state/new-hampshire/) - [New Jersey](https://isitonrecall.com/state/new-jersey/) - [New Mexico](https://isitonrecall.com/state/new-mexico/) - [Nevada](https://isitonrecall.com/state/nevada/) - [New York](https://isitonrecall.com/state/new-york/) - [Ohio](https://isitonrecall.com/state/ohio/) - [Oklahoma](https://isitonrecall.com/state/oklahoma/) - [Oregon](https://isitonrecall.com/state/oregon/) - [Pennsylvania](https://isitonrecall.com/state/pennsylvania/) - [Rhode Island](https://isitonrecall.com/state/rhode-island/) - [South Carolina](https://isitonrecall.com/state/south-carolina/) - [South Dakota](https://isitonrecall.com/state/south-dakota/) - [Tennessee](https://isitonrecall.com/state/tennessee/) - [Texas](https://isitonrecall.com/state/texas/) - [Utah](https://isitonrecall.com/state/utah/) - [Virginia](https://isitonrecall.com/state/virginia/) - [Vermont](https://isitonrecall.com/state/vermont/) - [Washington](https://isitonrecall.com/state/washington/) - [Wisconsin](https://isitonrecall.com/state/wisconsin/) - [West Virginia](https://isitonrecall.com/state/west-virginia/) - [Wyoming](https://isitonrecall.com/state/wyoming/) ## Dates in the source - **Report date**: Feb 4, 2026 - **Recall initiation date**: Dec 19, 2025 - **Center classification date**: Jan 27, 2026 FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1176-2026%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [Canon Medical System, USA, INC. records](https://isitonrecall.com/brand/canon-medical-system-usa-inc/)