AGFA Digital Radiography X- Ray system DR 800 with recall
AGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- a Tomographic X-ray system - Product Usage: TomoSynthesis is used to synthesize…
Why was AGFA Digital Radiography X- Ray system DR 800 with recalled?
Tomosynthesis image acquisition sequence did not stop automatically after expected number of exposures.
What should I do if I have this product?
Review the official FDA enforcement record for current 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: 00949, 1161
- Product
- AGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- a Tomographic X-ray system - Product Usage: TomoSynthesis is used to synthesize…
- Recalling firm
- Agfa N.V.
- Quantity
- 2 units
- Distribution
- US Nationwide distribution in the states of FL, VA.
- Recall date
- March 25, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)