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.
Siemens Medical Solutions USA, Inc
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-0298-2021Don't want to check this manually?
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