FDAClass IIAugust 14, 2024

Luminos recall

LUMINOS Lotus Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image Model Number: 11574100

Why was Luminos recalled?

The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays

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?

UDI: (01)04056869269931(21) Serial Numbers: Serial Number 10251 10181 10278 10274 10115 10309 10024 10140 10073 10327 10091 10307 10253 10117 10311 10030 10194 10029 10063 10076 10173 10172 10170 10079 10234 10330

Product
LUMINOS Lotus Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image Model Number: 11574100
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
26 units
Distribution
US Nationwide distribution.
Recall date
August 14, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls