FDA recall Z-1399-2018

Siemens Medical Solutions USA, Inc · Class II · device

Product

ONCOR Expression, Digital Linear Accelerator, Model No. 07360717 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.

Reason for recall

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.

Distribution

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.

Key facts

Status
Terminated
Initiation date
2018-02-14
Report date
2018-04-25
Termination date
2019-05-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Malvern, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1399-2018