FDA-Device2018-04-25Class II
PRIMUS HI, Digital Linear Accelerator, Model No. 04504200 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.
Siemens Medical Solutions USA, Inc
Hazard
Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment table.
Sold states
Worldwide Distribution- US Nationwide in the states: AL, CA, FL, GA, IL, IN, KY, MA, MI, MO, MS, NJ, NY, OH, OK, PA, RI, SC, TN, TX, WI, WV, and WY; and PR. International distribution to Nassau.
Affected count
18
Manufactured in
40 Liberty Blvd, Malvern, PA, United States
Products
PRIMUS HI, Digital Linear Accelerator, Model No. 04504200 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1402-2018Don't want to check this manually?
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