Z-1175-2026Class II

Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T; Siemens Material Number (SMN): 11574003; With...

Name: Z-1175-2026 Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T; Siemens Material Number (SMN): 11574003; With...
Creator: Siemens Medical Solutions USA, Inc
Published: 2025-12-29
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2025-12-29 / Open, Classified / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T; Siemens Material Number (SMN): 11574003; With Software Version VB10D-SP02 on 2025-12-29. FDA classified it as Class II and gives the reason as "Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be processed". 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-1175-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-12-29
Posted: 2026-01-27
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T; Siemens Material Number (SMN): 11574003; With Software Version VB10D-SP02
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be processed.
Root cause tag: software
FDA root cause: Software design
Action: On December 29, 2025 URGENT: MEDICAL DEVICE CORRECTION letters were sent to customers. Actions to be taken: Issue 1: Ortho images acquired with preset automatic horizontal flip are not flipped: For ortho examinations, no clinical protocols should be used where the automatic horizontal flip function is active. Issue 2: When acquiring single images, there is the possibility that an image of a previous patient may be processed: a. When acquiring single images with the Dynamic X.fluoro detector, the above-mentioned error message should be observed, and the system should be restarted when it appears. b. Images planned at the Bucky Wall Stand should be acquired on the basic unit or with a mobile detector. Should a single image on the Bucky Wall Stand in horizontal orientation be inevitable, the system must be restarted beforehand. How will the problem be resolved? Siemens Healthineers is preparing a software update to resolve the described problems. The new software version VB10E will be distributed via Update Instruction XP031/25/S during the first quarter of 2026 free of charge. Our service organization will contact you to arrange a date to perform this corrective action. Please feel free to contact our service organization at 1-800-888-7436 for an earlier appointment.
Quantity in commerce: 7 units
Distribution: Worldwide - US Nationwide distribution in the states of AK, CA, IL, MN, NY, OR, VA, WI and the countries of Austria, Belgium, Denmark, France, Germany, Greece, Ireland, Italy, Netherlands, Norway, South Africa, Spain, Sweden, Switzerland.
Product codes and lots: Siemens Material Number (SMN): 11574003; UDI-DI: 04056869993980; Serial Numbers: 170013, 170022, 170023, 170021, 170020, 170025, 170026;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1175-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1174-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-04	2026-01-27
Z-1175-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-04	2026-01-27

Product code OWB

K250660Class IILUMINOS Q.namix T; LUMINOS Q.namix RSiemens Medical Solutions / cleared 2025-07-14

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)