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Moderate riskFDA DeviceClass II

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

Fixing screws on the ceiling movement gear in Canon Medical's Alphenix INFX-8000F X-ray systems may become loose over time. This can prevent the ceiling arm from moving side to side, cause unusual noises, or trigger sensor errors during procedures.

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

What to do

  1. If your facility operates an affected system (check your serial number against the recall list), contact Canon Medical immediately for instructions
  2. Do not continue using the system if you notice ceiling movement problems, abnormal noise, or sensor errors
  3. Ask Canon Medical about inspection or repair options
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Alphenix INFX-8000F, interventional fluoroscopic x-ray system
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 4 products — see all of them.

Details

Units affected
98 units
Illnesses reported
None reported
Manufactured in
2441 Michelle Dr, N/A, Tustin, CA, United States
Classification
Class II
Recall number
Z-1177-2026

In the FDA's words

Description
Alphenix INFX-8000F, 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: W1C0582204, B2A1582208, W2A1052118, A3582035, A2A2362689, B2B18Y2813, W1D07Y2447, B4582113, W2A1042111, W1C0622270, A3592048, W4A11X2138, W2A09Y2060, B2A16Z2476, W2A09Y2066, W4A1122041, B2A1482032, B2A1482027, A2A2252435, W1D0722369, B2B15Y2247, W1B0542168, B2A1492049, W1D0722371, A2A2032031, A1C1972103, W4C1352375, B2B1862737, W1D0842499, W4A1212179, W4A11Z2171, W4A11Z2173, W1C0652298, B2A1692419, B2A1552170, A2A21Y2350, W4A1242226, B2B1952848, A1C19Z2180, B2A1662371, W1D0892555, W1D0822476, W1D06Z2356, B2A1682394, B2A17Y2619, B2A17Y2624, W1D0762406, A2A2172283, W4A11Y2155, A2A2272460, W1D0832487, B2B1822667, A1C1992146, W4A1112031, W4C1382409, A2A2292508, W4A13X2015, W4A1192130, B2A1712510, B2A1762562, W4A1142066, W1C0622274, A4552098, W4A12X2298, W1D0812460, A4542088, W1D0712363, A2A21X2348, W1C0552179, W4A1142065, B2A17Z2626, W4D13Y2444, W2A1042110, A2A20Z2159, W4A11Y2147, W1C0642289, B2B1852720, B2A1592219, W4B13Y2016, B2B1922843, B2B1822668, W4B12Y2312, A2A2052056, A2A2062062, A2A2072075, A2A2042041, A1C19Z2181, W2A1092163, A2A2012005, A2A20Y2147, A1C19Y2161, B2A1612289, W4A1112030, W2A0982042, B2B18X2802, B2A1712503, B2A1712499, B2A14Z2084. Distribution: Worldwide distribution - US Nationwide and the country of Dominican Republic. Affected quantity: 98 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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