FDA-Device2014-08-20Class II

Siemens Linear Accelerators of type ARTISTE, ONCOR, and PRIMUS with Automatic Sequenced Cancer Treatment Delivery Option.

Siemens Medical Solutions USA, Inc
Hazard

A safety risk exists with automatically sequenced treatment technique using the SIMTEC Auto Field Option where automatic movements of the gantry and the tabletop during an auto-sequenced treatment have the potential to lead to a collision with the patient.

Sold states
Nationwide and ROW, including Canada and Mexico.
Affected count
160
Manufactured in
51 Valley Stream Pkwy, N/A, Malvern, PA, United States
Products
Siemens Linear Accelerators of type ARTISTE, ONCOR, and PRIMUS with Automatic Sequenced Cancer Treatment Delivery Option.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2174-2014

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