AGFA Digital Radiography X- Ray system DR 800 with recall
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…
Why was AGFA Digital Radiography X- Ray system DR 800 with recalled?
Under specific conditions (Fluoroscopic exam, ABS=OFF, manual change of parameters) wrong calculation of the dose/minute for fluoroscopy exams can be possible
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: 0925, 0945, 0948, 0949, 1003, 1022, 1116, 1136, 1161, 1229, 1239, 1401, and 1404
- Product
- 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…
- Recalling firm
- Agfa N.V.
- Quantity
- 13 units
- Distribution
- US Nationwide distribution including in the sates of FL, IL, IN, LA, MA, MO, OH, SC, VA, WI.
- Recall date
- June 10, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)