[pending] Alphenix INFX-8000F, interventional fluoroscopic x-ray system
Pending LLM rewrite. Source: FDA_DEVICE Z-1177-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
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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