Z-0999-2026Class II

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

Name: Z-0999-2026 LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
Creator: Siemens Medical Solutions USA, Inc
Published: 2025-12-05
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2025-12-05 / Open, Classified / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471 on 2025-12-05. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0999-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-12-05
Posted: 2026-01-08
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: 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.
Root cause tag: software
FDA root cause: Radiation Control for Health and Safety Act
Action: The Customer Advisory Notice (CAN) was sent to the affected customer on December 5, 2025. The CAN notifies the customer of the problem and provides steps the user should take to avoid the problem until the resolution software update is available. When switching within five seconds from a table related OGP to a bucky wall stand related OGP with top-alignment and then back to a table related OGP, it may happen, that the collimation is not adapted to the limitations of the detector. The active radiation field may thus extend beyond the limits of the detector, resulting in radiation outside of the area of the detector.
Quantity in commerce: U.S.: 1, OUS: 95
Distribution: U.S. and OUS
Product codes and lots: (01)04056869269931(21)10330

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0999-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0999-2026	Class II	Ongoing	FDA Mandated	2026-01-14	2026-01-08

Product code OWB

K173639Class IILuminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom RaxSiemens Medi Cal Solutions, Inc. / cleared 2018-04-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)