Siemens Healthcare Gmbh
FDA adverse event reports naming Siemens Healthcare Gmbh as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: SIEMENS HEALTHCARE GMBH.
- Total reports
- 1,659
- Deaths
- 42
- Injuries
- 306
- Malfunctions
- 1,306
Reports per year
Source: FDA adverse event reports by year received, 2015–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Top device categories
- Interventional Fluoroscopic X-Ray SystemOWB814
- System, X-Ray, Tomography, ComputedJAK190
- Accelerator, Linear, MedicalIYE117
- System, Nuclear Magnetic Resonance ImagingLNH114
- System, X-Ray, Fluoroscopic, Image-IntensifiedJAA94
- System, Image Processing, RadiologicalLLZ64
- System, X-Ray, AngiographicIZI62
- System, X-Ray, MobileIZL48
- Computer, Diagnostic, ProgrammableDQK41
- System, X-Ray, StationaryKPR40
Recent recalls
- 2024-07-02Open, ClassifiedSoftware design
ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
A potential issue with ARTIS icono systems equipped with a small detector and a corresponding collimator (model # 10843101) was identified. In very rare situations, the first x-ray release following patient registration may be performed with incorrect copper prefiltration. If the described issue occurs, the applied radiation dose rate may be higher than intended by the user.
- 2024-07-02Open, ClassifiedSoftware design
ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
A potential issue with ARTIS icono systems equipped with a small detector and a corresponding collimator (model # 10843101) was identified. In very rare situations, the first x-ray release following patient registration may be performed with incorrect copper prefiltration. If the described issue occurs, the applied radiation dose rate may be higher than intended by the user.
- 2024-07-02Open, ClassifiedSoftware design
ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
A potential issue with ARTIS icono systems equipped with a small detector and a corresponding collimator (model # 10843101) was identified. In very rare situations, the first x-ray release following patient registration may be performed with incorrect copper prefiltration. If the described issue occurs, the applied radiation dose rate may be higher than intended by the user.
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