Medical Device Recall: Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Version VB10D-SP02
Siemens Medical Solutions USA, Inc · December 29, 2025
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.
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 Affected
NATIONWIDE
Quantity Affected
41 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1174-2026
Status: ongoing
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