Skip to content
Recall Observatory FDA recall evidence

Device product

ONCOR Impression , Digital Linear Accelerator, Model No. 05857920 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.

Z-1400-2018

February 14, 2018

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 79766
Status
Terminated
Classification
Class II
Quantity
7
Official record key
device-enforcement:Z-1400-2018

Official wording

Reason: 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.

Code information: Serial no:70-4143 70-4296 70-4235 70-4344 4021 3878 5154

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.