FDA-Device2021-01-20Class II
SOMATOM Force, Definition AS, Definition Edge, Definition Flash, Drive, Confidence and Edge Plus
Hazard
System does not trigger a cancel command followed by a reload of the scan with the new parameter(s). This issue may result in a delay in diagnosis and/or need for patient rescan
Sold states
US Nationwide
Affected count
3044
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
SOMATOM Force, Definition AS, Definition Edge, Definition Flash, Drive, Confidence and Edge Plus
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0771-2021More Siemens Medical Solutions USA, Inc recalls
- FDA-Device2026-07-08Siemens ARTIS icono ceiling monitor suspension recalled for loose screw risk
- FDA-Device2026-07-08Siemens ARTIS icono floor recalled for potential movement loss at detector height limits
- FDA-Device2026-07-08Siemens ARTIS icono biplane recalled for potential loss of movement after detector adjustment
- FDA-Device2026-07-08Siemens ARTIS icono ceiling model 11328100 recalled for loss of movement capability
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