FDAClass IIJanuary 25, 2023

AXIOM Luminos Agile recall

AXIOM Luminos Agile

Why was AXIOM Luminos Agile recalled?

There is potential for the footrest to detach from the patient table during use.

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?

All serial numbers for AXIOM Luminos Agile, Material #10502200 (no UDI)

Product
AXIOM Luminos Agile
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
271 units
Distribution
Worldwide distribution
Recall date
January 25, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls