FDA Medical devices recall ·
Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R recall
- Recall number
- Z-1174-2026
- Date
- (initiated December 29, 2025)
- Company / brand
- Siemens Medical Solutions USA, Inc
40 Liberty Blvd, Malvern, PA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 41 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Version VB10D-SP02
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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;
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.
States: Alaska California Illinois Minnesota New York Oregon Virginia Wisconsin
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1174-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.