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Canon Medical System, USA, INC. recalls INFX-8000V. For radiographic and fluoroscopic studies and intervention.
Recalled September 7, 2022 · FDA recall Z-1666-2022 · Canon Medical System, USA
Hazard
The fluoroscopic dose rate might exceed the conforming value during biplane fluoroscopy. · FDA Class II
Units
16 systems
Sold at
US Nationwide Distribution
Description
The fluoroscopic dose rate might exceed the conforming value during biplane fluoroscopy.
Product
INFX-8000V. For radiographic and fluoroscopic studies and intervention.
Manufacturer(s)
Canon Medical System, USA, INC.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →