Alphenix INFX-8000F, interventional fluoroscopic x-ray system
Pending LLM rewrite. Source: FDA_DEVICE Z-1177-2026.
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-8000F, 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: W1C0582204
- B2A1582208
- W2A1052118
- A3582035
- A2A2362689
- B2B18Y2813
- W1D07Y2447
- B4582113
- W2A1042111
- W1C0622270
- A3592048
- W4A11X2138
- W2A09Y2060
- B2A16Z2476
- W2A09Y2066
- W4A1122041
- B2A1482032
- B2A1482027
- A2A2252435
- W1D0722369
Distribution
Distributed nationwide across the United States.
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