medical Class II Updated 2026-02-04

Siemens Medical Solutions USA, Inc recalls Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R;

Recalled Product

Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Version VB10D-SP02


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
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, 150063;
View official government recall

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