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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NAEOTOM Alpha software applications are used in CT imaging to assess brain quantification and vessel hyperdensities. Healthcare providers purchase these applications to enhance diagnostic accuracy in medical imaging.
The software applications have not received FDA 510(k) clearance, which is necessary to ensure they meet safety and efficacy standards. Without this clearance, there is a risk of inaccurate diagnoses or treatment decisions.
This recall is not part of a broader industry pattern.
The recall affects healthcare providers using the NAEOTOM Alpha software, necessitating an immediate halt in usage. This may disrupt medical imaging services and could lead to delays in patient care.
The material number and serial numbers can typically be found on the product packaging or documentation provided with the software.
Expect a timeline of 4-6 weeks for any guidance or updates from Siemens regarding the recall.
Keep a record of all communications regarding the recall, including emails, letters, and notes from phone calls.
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.
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