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 MUSICA Dynamic Recalled by Agfa N.V. Due to Under specific conditions (Fluoroscopic exam, ABS=OFF, manual change...
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 MUSICA Dynamic, Type number: 6010/200 - Product Usage: DR 800: Agfa s DR 800 system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following anatomies/procedures: positioning fluoroscopy procedures, gastro-intestinal examinations, urogenital tract examinations, and angiography. It is intended to replace fluoroscopic images obtained through image intensifier technology. In addition, the system is intended for project radiography of all body parts. The DR 800 is not intended for mammography applications
Quantity: 13 units
Why Was This Recalled?
Under specific conditions (Fluoroscopic exam, ABS=OFF, manual change of parameters) wrong calculation of the dose/minute for fluoroscopy exams can be possible
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