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Canon Alphenix Ceiling Movement Gear Screws
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MEDICAL DEVICE RECALLMODERATE

Canon Alphenix Ceiling Movement Gear Screws

Canon recalls Alphenix X-ray systems (INFX-8000C/F/V) over loose ceiling gear screws.

What to do

Contact Canon Medical Systems to schedule inspection and repair of the ceiling movement gear screws. Do not use the system until the screws are verified and tightened.

Recalled
Listed
Updated
Recall No.
Z-3014-2026
Agency
FDA
Firm
Canon Medical System, USA, INC.
Recall ID
99222
Status
ONGOING

Recall at a glance

Quantity recalled
10 systems

Why it was recalled

Canon Medical Systems is recalling Alphenix X-ray interventional systems because the fixing screws of the ceiling movement gear in the ceiling-suspended arm may become loose, potentially causing the arm to move unexpectedly. The affected models are INFX-8000C, INFX-8000F, and INFX-8000V.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device

UDI-DI
30101165, 30093711, 30029686, 79000002, 30049491, 30100053, 30059175, 30059180, 30095017, 30097052

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Other Device Defect recalls

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Editorial summary by Recall Canary · summary updated 2026-08-26 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification