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.
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 SOMATOM X.ceed software applications: syngo.CT Brain Quantification, syngo.CT Vessel Hyperdensities, and syngo.CT ASPECTS. A total of two units are affected. These applications were distributed worldwide, including throughout the US, Canada, Costa Rica, India, and Israel.
The recalled software applications have not received the necessary FDA 510(k) clearance. This classification as Class II indicates a moderate risk of adverse health consequences.
No specific incidents or injuries have been reported related to the use of this software. However, the lack of FDA clearance raises significant concerns regarding patient safety.
Patients and healthcare providers must stop using the affected software immediately. They should contact Siemens Medical Solutions USA, Inc. or their healthcare provider for further instructions.
For more information, contact Siemens Medical Solutions USA, Inc. or visit the FDA recall notice at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1239-2026.
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