FDAClass IIAugust 14, 2024

Luminos dRF Max- Intended to visualize anatomical recall

Luminos dRF Max- Intended to visualize anatomical structures by converting an x-ray pattern into a visible image. Model Number: 10762471

Why was Luminos dRF Max- Intended to visualize anatomical 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: Serial Numbers: Serial Number 8320 8198 8334 8474 8183 8322 8613 8244 8660 8436 8095 8371 8378 7805 5664 5615 8150 8130 8300 8093 8468 7791 8479 7136

Product
Luminos dRF Max- Intended to visualize anatomical structures by converting an x-ray pattern into a visible image. Model Number: 10762471
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
24 units
Distribution
US Nationwide distribution.
Recall date
August 14, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls