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Alphenix INFX-8000F, interventional fluoroscopic x-ray… recallZ-1177-2026 · Canon Medical System, USA, INC. · initiated Dec 19, 2025

Class II Open, Classified All recalls posted in January 2026

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Canon Medical System, USA, INC. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Process design

What the company is doing

Canon Medical Systems USA issued an URGENT: MEDICAL DEVICE CORRECTION notice to its consignees on 12/19/2025 via letter. The notice explained the issue, risk to health, and requested the following: "Request to customers: Should the suspended device make an abnormal noise, or a sensor error is displayed before the corrective action is implemented on your system, please stop using the device and call your local Canon Service Team. Additionally, it is strongly requested that you share the contents of this letter with all users as well as clinical engineering or biomedical group at your facility. If you have any questions regarding this matter, please contact your service representative or contact our InTouch team at [email protected]."

Recall details

Recall number
Z-1177-2026
Recall class
Class II
Status
Open, Classified
Initiated by the company
Dec 19, 2025
Posted by the FDA
Jan 27, 2026
Recalling firm
Canon Medical System, USA, INC.
Quantity
98 units
Product code
OWB
FDA submissions
K182415
Distribution
Worldwide distribution - US Nationwide and the country of Dominican Republic.

Product description

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

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

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.

Other devices under the same FDA submission

1 device cleared under K182415 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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