Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
AGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- Recalled by Agfa N.V. Due to Tomosynthesis image acquisition sequence did not stop automatically...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Agfa N.V. directly.
Affected Products
AGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- a Tomographic X-ray system - Product Usage: TomoSynthesis is used to synthesize tomographic slices from a single tomographic sweep. The DR 800 is not intended for mammography applications
Quantity: 2 units
Why Was This Recalled?
Tomosynthesis image acquisition sequence did not stop automatically after expected number of exposures.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Agfa N.V.
Agfa N.V. has 7 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report