Siemens Medical Solutions USA Recalls

26 recalls found for Siemens Medical Solutions USA. Check if any of your products are affected.

HIGH
FDA DEVICE

ARTIS Pheno VE30A and VE40A, Model 10849000

During 3D acquisitions, lighter and darker patient images may be captured, which may result in less accurate 3D reconstruction. The variation of brightness is a result of a constant unregulated medium dose and the angular change of patient diameter caused by rotational acquisition. This may result in unintentional low-dose radiation exposure to a patient.

Siemens Medical Solutions USA
During 3D
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Health & Personal Care
HIGH
FDA DEVICE

Siemens ARTIS pheno and ARTIS Icono Imaging Systems Recalled for Dose-Display Anomaly (2026)

Siemens Medical Solutions USA recalled 758 units in the U.S. and 2,077 outside the U.S. of ARTIS pheno and ARTIS Icono imaging systems after a dose-display anomaly could misrepresent high X-ray doses. The devices may still be within regulatory dose limits, but the displayed dose may appear significantly higher. Clinicians should stop using the devices and await manufacturer guidance.

Siemens Medical Solutions USA
During patient
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Health & Personal Care
HIGH
FDA DEVICE

Siemens Recalls Interventional Fluoroscopic X-Ray System Over Imaging Risk

Siemens Medical Solutions USA recalled 40 units of its LUMINOS Q.namix R X-ray system on December 29, 2025. The recall addresses a defect that may result in images being incorrectly processed, potentially showing images from previous patients. Healthcare providers should stop using the device immediately and follow recall instructions.

Siemens Medical Solutions USA
Ortho images
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Health & Personal Care
HIGH
FDA DEVICE

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 Solutions USA
Ortho images
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Health & Personal Care
HIGH
FDA DEVICE

Siemens Medical Recalls NAEOTOM Alpha CT Software Over FDA Clearance Issue

Siemens Medical Solutions USA, Inc. recalled 88 units of NAEOTOM Alpha software applications on December 19, 2025. The applications lack FDA 510(k) clearance, posing potential risks to patient safety. Healthcare providers must stop using the software immediately and follow the manufacturer's instructions.

Siemens Medical Solutions USA
To remove
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Health & Personal Care
HIGH
FDA DEVICE

Siemens Medical Solutions Recalling CT Software Over Clearance Issues

Siemens Medical Solutions USA recalled two units of its NAEOTOM Alpha.Pro software applications on December 19, 2025. The recall affects software used in CT systems that lack FDA 510(k) clearance. Healthcare providers and patients must stop using the software immediately.

Siemens Medical Solutions USA
To remove
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Health & Personal Care
HIGH
FDA DEVICE

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 Solutions USA
To remove
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Health & Personal Care
HIGH
FDA DEVICE

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 Medical Solutions USA
To remove
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Health & Personal Care
HIGH
FDA DEVICE

Siemens Recalls LUMINOS Medical Imaging Systems Over Collimation Risk

Siemens Medical Solutions USA recalled LUMINOS Lotus Max and Luminos dRF Max systems on December 5, 2025. The recall affects systems with software version VF11 and involves a potential collimation error. Healthcare providers and patients must stop using the devices immediately.

Siemens Medical Solutions USA
A potential
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Health & Personal Care
HIGH
FDA DEVICE

Siemens MAMMOMAT Fusion Operator Table Recalled for Bus-Installation Risk (2025)

One unit of the Siemens MAMMOMAT Fusion operator table is recalled after being sold with a bus-installation kit. The device is not intended for bus installations and is designed for stationary operation. Health care providers should stop using the device immediately and follow the manufacturer’s recall instructions.

Siemens Medical Solutions USA
There were
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Health & Personal Care
HIGH
FDA DEVICE

Siemens Medical Solutions USA Recalls MAMMOMAT Inspiration Operator Table for Bus-Installation Risk

Siemens Medical Solutions USA recalls the MAMMOMAT Inspiration operator table. The recall covers six units worldwide, including three in the United States. The operator table was sold with a bus-installation kit and is not designed or released for bus installations. Stop using the device immediately and contact Siemens for instructions.

Siemens Medical Solutions USA
There were
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Health & Personal Care
HIGH
FDA DEVICE

Siemens MAGNETOM Verio Dot Upgrade MRI Recalled Over Ice Blockage Risk (46 Units) 2025

Siemens Medical Solutions USA recalled 46 MAGNETOM Verio Dot Upgrade MRI systems sold to hospitals worldwide after an ice blockage could prevent venting during a quench. The blockage could cause pressure to build in the helium containment system, potentially rupturing it and releasing helium into the scanning room. Hospitals and providers should stop using the device immediately and follow Siemens

Siemens Medical Solutions USA
There is
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Health & Personal Care
HIGH
FDA DEVICE

Siemens MAGNETOM Verio Dot MRI Recall 30 Units Over Ice Blockage Risk (2025)

Siemens Medical Solutions USA recalled 30 MAGNETOM Verio Dot MRI systems sold worldwide through hospitals and medical facilities. The ice blockage in the magnet venting system could trap helium during a quench, causing pressure buildup and a potential helium leak into the scanning room. Facilities should stop using the devices immediately and follow the manufacturer’s recall instructions.

Siemens Medical Solutions USA
There is
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Health & Personal Care
HIGH
FDA DEVICE

Siemens Medical Solutions USA BIOGRAPH One MRI System Recalled for Helium Leak Risk (1 Unit, 2025)

Siemens Medical Solutions USA issued an active recall for 1 unit of the BIOGRAPH One MRI System. The recall cites ice blockage in the magnet venting system that could prevent helium from escaping during a quench, risking rupture and helium leakage into the scanning room. Healthcare providers should follow the manufacturer’s recall instructions immediately.

Siemens Medical Solutions USA
There is
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Health & Personal Care
HIGH
FDA DEVICE

Siemens MAGNETOM Cima.X MRI Recall: 9 Units Worldwide (2025)

Siemens Medical Solutions USA recalled 9 MAGNETOM Cima.X MRI systems worldwide. A potential ice blockage in the magnet venting system could prevent helium from escaping during a quench, risking rupture and a helium leak into the scanning room. Hospitals and healthcare providers should stop using the devices and follow the manufacturer’s recall instructions.

Siemens Medical Solutions USA
There is
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Health & Personal Care
HIGH
FDA DEVICE

Siemens MAGNETOM Vida MRI Recall 237 Units Worldwide Over Ice Blockage Risk (2025)

Siemens Medical Solutions USA recalled 237 MAGNETOM Vida MRI scanners sold worldwide to healthcare providers. The recall cites ice forming in the magnet venting system. A quench could lead to a helium leak into the scanning room. Hospitals must stop using the devices and await manufacturer instructions.

Siemens Medical Solutions USA
There is
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Health & Personal Care
HIGH
FDA DEVICE

Siemens MAGNETOM Skyra MRI System Recall Covers 182 Units Over Ice Blockage Risk

Siemens Medical Solutions USA recalled 182 MAGNETOM Skyra MRI systems worldwide on August 28, 2025. The recall follows a potential ice blockage in the magnet venting system that could cause a helium leak during a quench. Hospitals should stop using affected devices and follow manufacturer instructions for remediation.

Siemens Medical Solutions USA
There is
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Health & Personal Care
HIGH
FDA DEVICE

Siemens MRI Recall: 18 MAGNETOM Skyra Fit BioMatrix Systems Recalled Over Helium Vent Blockage Risk

Siemens Medical Solutions USA recalls 18 MAGNETOM Skyra Fit BioMatrix MRI systems worldwide due to ice blockage in the magnet venting system that could trap helium gas during a quench. The risk is a ruptured helium containment and a potential helium leak into the scanning room. Hospitals and clinicians should stop using the affected devices and await manufacturer instructions.

Siemens Medical Solutions USA
There is
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Health & Personal Care
HIGH
FDA DEVICE

Siemens MAGNETOM Verio MRI Recalled Globally Over Ice Blockage Risk in Venting System

Siemens Medical Solutions USA recalls 69 MAGNETOM Verio MRIs worldwide after an ice blockage could trap helium gas during a quench. A rupture of the helium containment system may leak helium into the scanning room. The recall affects models with number 10276755 and serials including 40649 and others. Patients and providers should stop using the device and follow manufacturer instructions.

Siemens Medical Solutions USA
There is
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