February 3, 2026

Feb

FDA Recall: Removal of certain CT systems have not received FDA 510(k) clearance

February 3, 2026Allison PateNews

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 2/3/2026 Class: II PRODUCT: SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS Recall Number: Z-1239-2026 REASON: To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance. RECALLING FIRM/MANUFACTURER: Siemens Medical Solutions USA, Inc...

Feb

FDA Recall: Error with Windows 10. Stop use until device verified with Windows 11

February 3, 2026Allison PateNews

Company: Focalyx Technologies, LLC Date of Enforcement Report: 2/3/2026 Class: II PRODUCT: Focalyx Fusion Recall Number: Z-1243-2026 REASON: Software device that is an accessory for image-guided interventional and diagnostic procedures involving prostate has accessories that may not function properly with Windows 10, which may cause patient harm during biopsy or cause treatment/therapy delays, so firm...

FDA Recall: Removal of certain CT systems have not received FDA 510(k) clearance

FDA Recall: Error with Windows 10. Stop use until device verified with Windows 11

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FDA Recall: Removal of certain CT systems have not received FDA 510(k) clearance

FDA Recall: Error with Windows 10. Stop use until device verified with Windows 11

Upcoming Public Courses

Corporate Office