Alphenix INFX-8000V, interventional fluoroscopic x-ray system
Pending LLM rewrite. Source: FDA_DEVICE Z-1179-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
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
The recalled product
- Product
- Alphenix INFX-8000V, interventional fluoroscopic x-ray system
- Manufacturer
- Canon Medical System, USA, INC.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- serial numbers: B2A1522117
- E0514103
- B2A15X2238
- B2A1792589
- A2A2242418
- A2A21X2345
- B2A1692413
- A2A2152263
- A2A2262450
- A2A22Z2576
- W4A1252250
- A2A20Z2167
- W4A10X2001
- A2A2412831
- W1C0552181
- W1D0842501
- W4D13Z2452
- W4A1322350
- W4D1422467
- B2A1472002
Distribution
Distributed nationwide across the United States.
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