FDAClass IIJanuary 14, 2026

Luminos recall: Software Issue

LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471

Why was Luminos recalled?

A potential issue associated with LUMINOS Lotus Max and Luminos dRF Max systems with software version VF11 with bucky wall stand for mobile detectors and without ceiling stand .When switching quickly between organ programs (OGPs) the collimation may be incorrect.

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?

(01)04056869269931(21)10330

Product
LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
U.S.: 1, OUS: 95
Distribution
U.S. and OUS
Recall date
January 14, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls