FDA-Device2026-02-04Class II
Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Version VB10D-SP02
Siemens Medical Solutions USA, Inc
Hazard
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.
Sold states
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.
Affected count
41 units
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Version VB10D-SP02
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1174-2026Don't want to check this manually?
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