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.
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Siemens Medical Solutions USA, Inc or your healthcare provider for instructions. Notification method: Letter
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The recall affects NAEOTOM Alpha software applications: syngo.CT Brain Quantification, syngo.CT Vessel Hyperdensities, and syngo.CT ASPECTS. The software was distributed worldwide, including the US, Canada, Costa Rica, India, and Israel.
The applications have not received FDA 510(k) clearance, which is necessary for medical devices to ensure safety and efficacy. The lack of clearance can lead to misdiagnosis or improper treatment.
There are no specific reported injuries or incidents associated with this software's use. However, the lack of FDA clearance raises significant concerns about potential risks.
Patients and healthcare providers should cease using the software immediately. Contact Siemens Medical Solutions USA, Inc. or your healthcare provider for detailed instructions on the recall.
For more information, contact Siemens Medical Solutions USA, Inc. or visit the recall notice at the FDA website.
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