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U.S. Department of Health and Human Services

Class 2 Device Recall LUMINOS Q.namix T

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 Class 2 Device Recall LUMINOS Q.namix Tsee related information
Date Initiated by FirmDecember 29, 2025
Date PostedJanuary 27, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1175-2026
Recall Event ID 98244
510(K)NumberK250660 
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
ProductInterventional Fluoroscopic X-Ray System: LUMINOS Q.namix T; Siemens Material Number (SMN): 11574003; With Software Version VB10D-SP02
Code Information Siemens Material Number (SMN): 11574003; UDI-DI: 04056869993980; Serial Numbers: 170013, 170022, 170023, 170021, 170020, 170025, 170026;
FEI Number 2240869
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information ContactRebecca Tudor
484-323-4198
Manufacturer 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.
FDA Determined
Cause 2		Software design
ActionOn 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.
Quantity in Commerce7 units
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = OWB
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