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Siemens Medical Solutions USA Recalls
- Active recalls
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Siemens ARTIS pheno and ARTIS Icono Imaging Systems Recalled for Dose-Display Anomaly (2026)
ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system
ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model 11328100. ARTIS icono floor Model 11327700. interventional fluoroscopic x-ray system
Siemens Recalls Interventional Fluoroscopic X-Ray System Over Imaging Risk
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.
Siemens X-Ray System Recalled Due to Image Processing Errors
Siemens Medical Solutions USA recalled five LUMINOS Q.namix T X-ray systems on December 29, 2025. The recall affects devices that can process images from previous patients due to a software issue. Healthcare providers must stop using these devices immediately.
Siemens Medical Recalls NAEOTOM Alpha CT Software Over FDA Clearance Issue
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
Siemens Medical Solutions Recalling CT Software Over Clearance Issues
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
Siemens Medical Recalls Software Due to Lack of FDA Clearance
Siemens Medical Solutions recalled software applications for certain CT systems on December 19, 2025. The applications did not receive FDA 510(k) clearance. Five units distributed worldwide are affected by this recall.
Siemens Medical Recalls CT Software Over FDA Clearance Issues
Siemens Medical Solutions USA recalled two units of its CT software applications on December 19, 2025. The software lacks FDA 510(k) clearance, posing potential risks to patients. Healthcare providers should stop using the affected software immediately.
Siemens Recalls LUMINOS Medical Imaging Systems Over Collimation Risk
Siemens MAMMOMAT Fusion Operator Table Recalled for Bus-Installation Risk (2025)
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.
Siemens Medical Solutions USA Recalls MAMMOMAT Inspiration Operator Table for Bus-Installation Risk
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.