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.
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 Siemens Medical software applications: syngo.CT Brain Quantification, syngo.CT Vessel Hyperdensities, and syngo.CT ASPECTS. The affected software is associated with Material Number 11549431. The recall applies to five units identified by serial numbers 183046, 183047, 183048, 183050, and 183051.
The software applications did not receive necessary FDA 510(k) clearance, posing risks in clinical usage. The lack of clearance means the software may not have met safety and effectiveness standards required for medical devices.
No incidents, injuries, or deaths have been reported due to the use of the affected software applications.
Patients and healthcare providers should stop using the software immediately. Follow the recall instructions provided by Siemens Medical Solutions USA, Inc. Contact your healthcare provider for further instructions.
For more information, contact Siemens Medical Solutions USA, Inc. Details can be found on the FDA's recall page at the provided URL.
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