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Moderate riskFDA DeviceClass II

Canon Medical Alphenix INFX-8000C X-ray system recalled for loose ceiling screws

Fixing screws in the ceiling-mounted arm of Canon Medical's Alphenix INFX-8000C interventional X-ray systems may become loose. This can cause the ceiling arm to stop moving sideways, create unusual noises, or trigger sensor errors during use.

From the FDA notice · Read the official notice ↗ · All Canon recalls

What to do

  1. If you operate this equipment, contact Canon Medical System USA immediately with your system's serial number
  2. Do not use the ceiling lateral movement feature until the screw issue is inspected and corrected
  3. Check the affected serial numbers list to confirm whether your unit is involved
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Alphenix INFX-8000C, interventional fluoroscopic x-ray system
Sold in
Nationwide
Made for
All ages (under 100 years)

This recall covers 4 products — see all of them.

Details

Units affected
172 units
Illnesses reported
None reported
Manufactured in
2441 Michelle Dr, N/A, Tustin, CA, United States
Classification
Class II
Recall number
Z-1176-2026

In the FDA's words

Description
Alphenix INFX-8000C, interventional fluoroscopic x-ray system 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 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. Distribution: Worldwide distribution - US Nationwide and the country of Dominican Republic. Affected quantity: 172 units
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

4 products in this recall

The agency lists each product separately. Check every one you might have.

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