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.
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 involves NAEOTOM Alpha.Pro software applications: syngo.CT Brain Quantification, syngo.CT Vessel Hyperdensities, and syngo.CT ASPECTS. These applications have not received the necessary FDA 510(k) clearance. The products were distributed worldwide, including the US, Canada, Costa Rica, India, and Israel.
The software applications lack FDA clearance, which raises concerns about their safety and effectiveness. Using unapproved software in medical devices may lead to misdiagnosis or incorrect treatment.
There are no reported incidents of injuries or deaths related to this recall. The software's lack of clearance is the primary concern.
Stop using the software applications immediately. Contact Siemens Medical Solutions USA, Inc. or your healthcare provider for further instructions. Follow the recall instructions provided by the manufacturer.
For more information, contact Siemens Medical Solutions USA at their official website or refer to the recall notification letter.
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