Canon Medical System, USA, INC.: Interventional Fluoroscopic X-Ray System
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It has been found that when SPOT Fluoro is first turned on, the default ROI is selected and the collimator blades move to the boundary of the ROI, and the static image is overlayed around the ROI, covering the collimated area. If the customer changes the ROI, the collimator blades and static images are adjusted accordingly. However, when the acquisition program is changed, the collimator returns to the default ROI position which may be larger than the specified one, leaving the X-ray area partially covered by the static image. This is a software problem with the SPOT Fluoro program and will not occur if the function is not used.
- Tags
- FDA recall, medical device, class 2, Radiology, Radiation Control for Health and Safety Act, Open, Classified
- Related exam domains
- CISSP 3: Security Architecture and Engineering; CISSP 8: Software Development Security; CISM 3: Information Security Program
- Source record id
- Z-0037-2026
- First seen by InfoSec Signals
- Sep 23, 2026
Source: openFDA device recalls, U.S. Food and Drug Administration about this source more from it
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