Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Version VB10D-SP02
Reported: February 4, 2026 Initiated: December 29, 2025 #Z-1174-2026
Product Description
Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Version VB10D-SP02
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.
Details
- Recalling Firm
- Siemens Medical Solutions USA, Inc
- Units Affected
- 40 units
- Distribution
- Worldwide - US Nationwide distribution in the states of AK, IL, NY, VA, WI and the countries of Austria, Belgium, Denmark, France, Germany, Greece, Ireland, Italy, Netherlands, Norway, South Africa, Spain, Sweden, Switzerland.
- Location
- Malvern, PA
Frequently Asked Questions
What product was recalled? ▼
Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Version VB10D-SP02. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 40 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 4, 2026. Severity: Moderate. Recall number: Z-1174-2026.
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