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Siemens Medical Solutions USA, Inc recalls ONCOR Impression Plus, Digital Linear Accelerator, Model No. 05857912 Product Usage: The intended use of the device
Recalled April 25, 2018 · FDA recall Z-1401-2018 · Siemens Medical Solutions USA
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. · FDA Class II
Units
15
Sold at
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.
Description
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.
Product
ONCOR Impression Plus, Digital Linear Accelerator, Model No. 05857912 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.
Manufacturer(s)
Siemens Medical Solutions USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →