Brand name: AGFA Digital Radiography X- Ray system DR recall
Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800
Why was Brand name: AGFA Digital Radiography X- Ray system DR recalled?
It is possible to exceed the maximum allowed Air Kerma rate (AKR) of 88mGy/min for pulsed fluoro exams. This can happen in case the framerate is increased on the NX workstation when ABS is not enabled.
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?
N/A
- Product
- Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800
- Recalling firm
- AGFA Healthcare Corp.
- Quantity
- 35
- Distribution
- U.S. Nationwide distribution.
- Recall date
- December 31, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)