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RecallWatchMedical Device Safety
Class IIOngoingZ-1176-2026

Canon Medical System, USA, INC. recalls Alphenix INFX-8000C

Canon Medical System, USA, INC.Tustin, CA, United StatesReported Feb 4, 2026 · 5 months ago
Legal News Analyst ·

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

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • Alphenix INFX-8000C, interventional fluoroscopic x-ray system
    172 affected lots
    W1C0632284W4A1282279W4A12Z2324A2A2222381A2A2392756A3517001A2A2352683A2A2072087
    +164 moreA2A2072077C1C2422647W2A09Y2061W2A10X2168W4A11Y2144A2A2232406A2A2032038W1D07Z2458W2A09X2053B2B1812645A1C19Z2182W4B1332362B2A1622324W4C1352385W4A1292284A1C19X2152A1C1942058A1C1972104B2A1592233B2A1792598W2A1012081W2A1052121W4C1342374B2B1872766A4562105W2A0972027A1C2052199A2A21X2339W2A1012082W4C1342369W1D07Z2449A1C1942065A2A2132228A2A2172285A2A2117001W1D06Z2357A2A2282477A2A2232405W1B08X2034A2A2182313W4A1232210A2A2262452B2A16X2449B2B1862743B2B1872751W1D0697014W1C05X2229B2A1542162A2A21Z2364A2A2392751B2A1722527A2A22Z2566B4582115W4C1372400A2A2362690A2A2252436A2A2292510B2A1582209B2A1472014W1D0732376A2A2252439W1D0732374A1C1972105A1C1972112B4602126W1B08Z2063A2A2152265A2A2132230A2A2282491A2A2262445A2A22Y2550A2A22X2528W4A1212180W4A1212176W4A1212177A1C1992141W4A1182110W4A11Z2163W1D0812466B2B18Y2816B2B1832693A1C1952078A2A2062070W2A09Z2077A1C19Y2174W1D0722372A2A22X2518A3542008B2A1472020W4A1242224W4A1312348A2A2172280W4D1422466W4A1142069A2A2172287A2A2342657A2A2432872B2A1552176B2B1812657B2B1872765W4A1342373B2A1682407W4A11Z2170W4C1342364W4C1342365W4A1172092A2A2172281W2A1072143W4A1292281A2A2242426A2A2392761A3612061A1A2162240A2A23Z2814B2B1872760A2A2262456A1C2042197B2A14Z2085W4C1352377W4A1252245A1C19Z2178A2A2292499W4A1242221W1D0872524A1C19Z2188A1C19X2158A2A2052053B2B1862731B2A1752550B2B1832678B2B1852708B2B1852710B2B1852707W1C0582207W1C05Y2242W1D0722370W4A1272267W2A1062127B2A1742539B2B1922842A2A2062066B2A16Y2469W4A1122048B2A1662369W4A1122039B5512160A2A2122205B2B1822664B2B1822670A2A2292498W4D13Y2442A2A2122197A2A2192330A2A2132216A2A22X2522A2A2432885A2A2422855W2A1012091W1C05X2224B2A1622310A1C1972111B2B1892787A1C1952080A1B18Y7002

What the firm 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 intouchdispatch@us.medical.canon."

DistributionShow details

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

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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