—#218008

Product

Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Version VB10D-SP02

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K250660
Affected lot / code info: Siemens Material Number (SMN): 11574002; UDI-DI: 04056869993973; Serial Numbers: 150050, 150035, 150033, 150034, 150048, 150021, 150020, 150053, 150023, 150044, 150049, 150037, 150054, 150011, 150059, 150024, 150038, 150051, 150029, 150045, 150032, 150056, 150043, 150055, 150041, 150026, 150025, 150022, 150031, 150039, 150046, 150042, 150028, 150047, 150030, 150052, 150027, 150057, 150040, 150058, 150063;

Why it was recalled

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 (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2025-12-29
Posted by FDA: 2026-01-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #218008. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.