Siemens Medical Solutions USA Recalls

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

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
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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 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
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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.

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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.

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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.

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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.

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Health & Personal Care
HIGH
FDA DEVICE

Siemens Recalls MAMMOMAT Inspiration Operator Tables Due to Hazard

Siemens Medical Solutions USA recalled six MAMMOMAT Inspiration operator tables on October 24, 2025. The operator tables were sold with a bus-installation kit, which they are not designed for. This recall affects three units in the U.S. and three internationally.

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Health & Personal Care
HIGH
FDA DEVICE

Siemens Medical Solutions Recalls MAMMOMAT Fusion Operator Table

Siemens Medical Solutions USA recalled one MAMMOMAT Fusion operator table on October 24, 2025. The table was sold with a bus-installation kit but is intended for stationary use only. This recall affects distribution in Arkansas, California, New York, and internationally in Australia, Canada, and India.

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Health & Personal Care
HIGH
FDA DEVICE

Siemens MRI Scanner Recalled Due to Helium Leak Risk

Siemens Medical Solutions USA recalled 237 MAGNETOM Vida MRI scanners on August 28, 2025. The recall stems from a potential ice blockage in the magnet venting system which may cause helium leaks. The affected model number is 11060815, distributed worldwide, including the U.S.

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Health & Personal Care
HIGH
FDA DEVICE

Siemens Medical MRI Machines Recalled Over Helium Leak Risk

Siemens Medical Solutions USA recalled 18 MAGNETOM Skyra Fit BioMatrix MRI machines on August 28, 2025. The recall addresses a potential ice blockage in the magnet venting system, which could lead to helium gas leaks. Users must stop using the devices immediately and follow recall instructions.

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Health & Personal Care
HIGH
FDA DEVICE

Siemens Medical MRI Machines Recalled Over Helium Leak Risk

Siemens Medical Solutions USA recalled 71 MRI machines on August 28, 2025. Ice blockages in the venting system may cause helium leaks. The recall affects models distributed worldwide, including the U.S.

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Health & Personal Care
HIGH
FDA DEVICE

Siemens MRI System Recalled Due to Helium Leak Risk

Siemens Medical Solutions USA recalled 69 units of the MAGNETOM Verio MRI system on August 28, 2025. Ice blockage in the magnet venting system could lead to a helium leak, posing serious risks. Healthcare providers must stop using the device immediately and follow recall instructions.

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Health & Personal Care
HIGH
FDA DEVICE

Siemens Medical MRI Scanner Recalled Over Helium Leak Risk

Siemens Medical Solutions USA recalled one MRI scanner model due to a risk of helium leaks. The recall affects one unit distributed worldwide as of August 28, 2025. Users must stop using the device immediately and follow manufacturer instructions.

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Health & Personal Care
HIGH
FDA DEVICE

Siemens Medical Recalls MAGNETOM Verio Dot Over Helium Leak Risk

Siemens Medical Solutions USA recalled 46 MAGNETOM Verio Dot systems on August 28, 2025. The recall stems from a risk of ice blockage in the magnet venting system. This could lead to a helium leak, posing serious safety hazards.

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Health & Personal Care
HIGH
FDA DEVICE

Siemens Medical Solutions Recalls BIOGRAPH One Due to Helium Leak Risk

Siemens Medical Solutions USA recalled one BIOGRAPH One MRI system on August 28, 2025. The recall affects model number 11689172 due to a potential helium leak risk. Patients and healthcare providers must stop using the device immediately and follow the manufacturer’s instructions.

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Health & Personal Care
HIGH
FDA DEVICE

Siemens Medical Recalls MRI Machine Over Helium Leak Risk

Siemens Medical Solutions USA recalled 182 MRI machines on August 28, 2025, due to a risk of helium leaks. An ice blockage in the magnet venting system could cause pressure build-up, leading to a potential rupture. Users must stop using the device and follow recall instructions immediately.

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Health & Personal Care
HIGH
FDA DEVICE

Siemens MRI Scanner Recalled Due to High Pressure Risk

Siemens Medical Solutions USA recalled nine MRI scanners on August 28, 2025. The devices may develop ice blockages in the venting system, risking helium leaks. Healthcare providers must stop using the scanners immediately.

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Health & Personal Care
HIGH
FDA DEVICE

Siemens MRI Device Recalled Due to Helium Leak Risk

Siemens Medical Solutions USA recalled 27 units of its MAGNETOM Vida Fit MRI system on August 28, 2025. The recall addresses a risk of ice blockage that can cause helium gas pressure build-up. This defect may lead to a helium leak in the scanning room, posing a safety hazard.

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Health & Personal Care
HIGH
FDA DEVICE

Siemens Medical MRI Scanner Recalled Due to Helium Leak Risk

Siemens Medical Solutions USA recalled the MAGNETOM Connectom.X. MRI Scanner on August 28, 2025. The recall affects one unit worldwide due to a potential helium leak risk. Users must stop using the device immediately as it poses a high hazard level.

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Brand Statistics

Total Recalls
25
Pages
2