FDA-Device2022-12-21Class II
ARTISTE, ONCOR and PRIMUS with syngo RT Therapist with software version 4.3.1 MR3. Material Number: 8162815 Intended Use: Family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer.
Siemens Medical Solutions USA, Inc
Hazard
When selecting the site fraction group for treatment, the User may select the wrong site for treatment, and potentially deliver the dose to wrong isocenter
Sold states
US Nationwide distribution in the states of CA, IA, LA, NE, NV, OH, SC.
Affected count
8 units US
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
ARTISTE, ONCOR and PRIMUS with syngo RT Therapist with software version 4.3.1 MR3. Material Number: 8162815 Intended Use: Family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0472-2023Don't want to check this manually?
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