This device is a digital radiography/fluoroscopy system recall: Software Issue
This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for…
Why was This device is a digital radiography/fluoroscopy system recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial Numbers: SZA2422001, SXA2432001, SUC23Z2014, BBF2392003, SUC2392013, SZA2422002, SXA2432002, SZA2442004.
- Product
- This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for…
- Recalling firm
- Canon Medical System, USA, INC.
- Quantity
- 8
- Distribution
- U.S.
- Recall date
- October 15, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)