The FDA has posted 41 enforcement recalls from Siemens Medical Solutions USA, Inc since 2025, including 16 Class I (most serious) recalls. Most recent report: Jul 8, 2026.
Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.
Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.
Potential issue with the Display ceiling suspension (DCS Fix XL) that holds the monitor in place. Over time some screws that keep the monitor attached to the suspension may gradually loosen.
Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.
During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions.…
During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions.…
During 3D acquisitions, lighter and darker patient images may be captured, which may result in less accurate 3D reconstruction.…
During patient examinations, the system may sporadically display a major increase of the x-ray dose applied to the patient.…
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
Firm name as filed with the FDA: “Siemens Medical Solutions USA, Inc”. Related firm entities may file under separate names. Source: U.S. FDA openFDA device enforcement reports. Informational only — verify with the FDA before acting.