Luminos Lotus Max, Model 11574100 And Luminos Drf Max, Model 10762471

Recall Summary Siemens is recalling LUMINOS Lotus Max (Model 11574100) and Luminos dRF Max (Model 10762471) X-ray systems with certain software versions when used with a bucky wall stand and mobile detectors. When users quickly switch between organ programs, the collimation—which controls the X-ray beam size and shape—may not adjust correctly. This is a Class II recall affecting medical facilities using these specific system configurations.

Recalling firm

Siemens Medical Solutions USA, Inc

Product

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

Reason

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.

Classification

Class II

Category

consumer product recall

Country

United States

Agency

FDA-DEVICES

Recall date

2025-12-05

Status

Open, Classified

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/3edc7cc8-5ae9-41ca-80f5-7e5940e73518