FDA-Device2022-01-05Class II
ARTISTE with syngo RT Therapist-linear accelerator systems to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. Model Number: 8162815
Siemens Medical Solutions USA, Inc
Hazard
Potential safety issue under specific preconditons that may result in a user selecting the wrong site for treatment with the possibility to deliver dose to the wrong isocenter which could result in serious patient injury
Sold states
US Nationwide distribution in the states of IA, LA, NE, NJ, NV, NY, OH, PA, SC, SD.
Affected count
13 units
Manufactured in
40 Liberty Blvd, Malvern, PA, United States
Products
ARTISTE with syngo RT Therapist-linear accelerator systems to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. Model Number: 8162815
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0441-2022Don't want to check this manually?
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