Canon Medical Alphenix INFX-8000 Systems Recall
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Canon Medical System, USA, INC. is recalling 10 Alphenix interventional X-ray systems due to potential loose fixing screws in the ceiling suspended arm.
Reading this FDA recall beyond the headline
This notice was issued by FDA on September 9, 2026 and geographically references United States. The FDA classifies this as a Class II recall, with the stated reason "Due to the fixing screws of ceiling movement gear in ceiling suspended arm that are part of the X-ray interventional systems may become loose.", distributed u.s. nationwide distribution in the states of ca, ga, mn, nc, nv, pa, oh, and tx.. FDA recall classes run from I (reasonable probability of serious harm) to III (unlikely to cause harm), so the class number is the fastest way to gauge severity here. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
A quick skim tells you whether this affects you directly; a closer read tells you more. Check the scope, the source, and how recent the record is, then weigh it against related notices rather than treating any single one as a trend.
Before acting, the primary agency source is available to check alongside this summary. Its related labels are recall, product-safety, fda, Devices.
What Happened
The fixing screws of ceiling movement gear in ceiling suspended arm that are part of the X-ray interventional systems may become loose.
Which Products Are Affected
Alphenix Models INFX-8000C, INFX-8000F, INFX-8000V. This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities. 10 systems distributed in the states of CA, GA, MN, NC, NV, PA, OH, and TX. Affected units include specific model/serial number combinations listed under recall number Z-3014-2026.
What You Should Do
Consumers should contact Canon Medical System, USA, INC. regarding the recall.
Why This Matters
The recall affects 10 systems in eight states and involves a Class II device used in diagnostic and interventional procedures.
Source
FDA recall Z-3014-2026
Original source: FDA Official Notice ↗
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Similar notices nationwide by length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (968 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to September 9, 2026.
Common Questions
Common questions about this FDA recall.