FDAClass IIAugust 7, 2019

AGFA Digital Radiography X- Ray system DR 800 with recall

AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Product Usage: The Agfa s DR 800 system is indicated for performing dynamic imaging…

Why was AGFA Digital Radiography X- Ray system DR 800 with recalled?

The exposed area of fluo exams possibly does not match the active area of the detector within specified limits.

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?

Model/Serial Number/s: 00925, 00945, and 00949, 1136

Product
AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Product Usage: The Agfa s DR 800 system is indicated for performing dynamic imaging…
Recalling firm
Agfa N.V.
Quantity
4
Distribution
US Nationwide Distribution
Recall date
August 7, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
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