Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Version VB10D-SP02
- Recall Initiated
- December 29, 2025
- Posted
- January 27, 2026
- Recall Number
- Z-1174-2026
- Quantity
- 40 units
- Firm Location
- Malvern, PA
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, IL, NY, VA, WI and the countries of Austria, Belgium, Denmark, France, Germany, Greece, Ireland, Italy, Netherlands, Norway, South Africa, Spain, Sweden, Switzerland.
Lot / Code Info
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;
Root Cause
Software design
Action Taken
On 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.