FDA-Device2020-11-04Class II
Siemens Artis one systems with a Display Port transceiver-Fluoroscopic X-Ray System Model: 10848600 - Product Usage: he examination table as an integrated part of the system can be used for X-ray imaging, surgery and interventions. The Artis one can also support the acquisition of position triggered imaging for spatial data synthesis.
Hazard
Potential malfunction in which the examination room monitor may become intermittently dysfunctional (e.g., no display/flicking/wrong resolution).
Sold states
US Nationwide distribution including in the states of AL, AR, AZ, CA, FL, IN, LA, MI, MO, NC, NJ, NY, PA, TX, WA.
Affected count
22 units
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
Siemens Artis one systems with a Display Port transceiver-Fluoroscopic X-Ray System Model: 10848600 - Product Usage: he examination table as an integrated part of the system can be used for X-ray imaging, surgery and interventions. The Artis one can also support the acquisition of position triggered imaging for spatial data synthesis.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0298-2021More 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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