FirstAlerts

Canon Medical recalls Alphenix X-ray systems over loose ceiling arm screws

FDA classifies the action as Class II, saying the screws may become loose and the chance of serious harm is remote.

By AI ReporterWritten Sep 7, 2026, 8:36 p.m. ET
, of , California, initiated a recall of certain Alphenix X-ray systems on August 4, 2026, according to an FDA enforcement report dated September 2, 2026. The recall, listed as number , covers distributed nationwide in California, Georgia, Minnesota, North Carolina, Nevada, Pennsylvania, Ohio, and Texas. The affected models are INFX-8000C, INFX-8000F, and INFX-8000V. The FDA report states that the fixing screws of the ceiling movement gear in the ceiling-suspended arm may become loose. The recall is and classified as , the FDA's middle category, used when a product may cause temporary or medically reversible harm and the chance of serious harm is remote, according to the FDA's recall definitions. The FDA enforcement database records no other enforcement action by this firm.

Was this report accurate and useful?

Sources

Revision history

  1. Version 18 Sept 2026, 00:36current

    First published.

How we work

This site models an investigative reporter rather than a wire desk. The aim is the most complete, accurate and timely account we can assemble — all three, not a trade between them. Reports go out within minutes of the coverage they are built from, carrying context a newsroom would otherwise need a day and a records request to gather: what has happened at this place before, what the operator’s record is, which aircraft it actually was.

Reports are built from primary sources — accident and court records, official registries, weather observations, agency statements — and from reputable news organisations, each named where their reporting is used. Facts are extracted before anything is written, and every one must be supported by a quotation found in the source itself; the model that writes the report is given only those verified facts and never sees the article, so it cannot introduce a detail no source stated.

Where sources disagree we publish the disagreement, attributed, rather than picking a figure. Where a fact comes from a record rather than a reporter, we say so, and the language matches: an instrument reading is never described as something anyone confirmed. Some things are deliberately withheld — a suspect is not named until an agency names them on the record, victims until families or officials release them — and corrections appear as visible revisions, never as silent edits.

None of that makes a report true. A quotation check proves a source said something, not that it was right, and an automated system can be confidently wrong in ways the checks do not catch. If something here is wrong, the feedback above is how it gets found. The full methodology, including what we refuse to publish.