Siemens Medical Solutions USA, Inc.
FDA adverse event reports naming Siemens Medical Solutions USA, Inc. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: SIEMENS MEDICAL SOLUTIONS USA, INC..
- Total reports
- 2,020
- Deaths
- 13
- Injuries
- 181
- Malfunctions
- 1,641
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Transducer, Ultrasonic, DiagnosticITX484
- System, Imaging, Pulsed Doppler, UltrasonicIYN334
- Catheter, Ultrasound, IntravascularOBJ323
- Accelerator, Linear, MedicalIYE312
- System, Imaging, Pulsed Echo, UltrasonicIYO155
- System, Nuclear Magnetic Resonance ImagingLNH51
- System, X-Ray, Tomography, ComputedJAK50
- System, Tomography, Computed, EmissionKPS50
- System, X-Ray, AngiographicIZI43
- System, X-Ray, Fluoroscopic, Image-IntensifiedJAA40
Recent recalls
- 2026-07-01Open, ClassifiedSoftware design
ARTIS icono biplane. Model Number: 11327600.
Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.
- 2026-07-01Open, ClassifiedSoftware design
ARTIS icono ceiling. Model Number: 11328100.
Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.
- 2026-07-01Open, ClassifiedSoftware design
ARTIS icono floor. Model Number: 11327700.
Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.
- 2026-07-01Open, ClassifiedDevice Design
ARTIS icono ceiling. Model Number: 11328100.
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.
- 2026-06-04Open, ClassifiedRadiation Control for Health and Safety Act
ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system
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. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient.
- 2026-06-04Open, ClassifiedRadiation Control for Health and Safety Act
ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model 11328100. ARTIS icono floor Model 11327700. interventional fluoroscopic x-ray system
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. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient.
- 2026-04-16Open, ClassifiedRadiation Control for Health and Safety Act
ARTIS Pheno VE30A and VE40A, Model 10849000
During 3D acquisitions, lighter and darker patient images may be captured, which may result in less accurate 3D reconstruction. The variation of brightness is a result of a constant unregulated medium dose and the angular change of patient diameter caused by rotational acquisition. This may result in unintentional low-dose radiation exposure to a patient.
- 2026-04-07Open, ClassifiedRadiation Control for Health and Safety Act
ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.
During patient examinations, the system may sporadically display a major increase of the x-ray dose applied to the patient. Despite the reported dose showing significantly higher, the actual applied x-ray dose levels are in accordance with the system settings and imaging conditions, as well as the applicable regulatory requirements.
- 2026-02-03Open, ClassifiedUnder Investigation by firm
SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
- 2026-02-03Open, ClassifiedUnder Investigation by firm
NAEOTOM Alpha Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
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