Device product
Siemens Digital Linear Accelerators of type: ARTISTE MV System MEVATRON M2/Primus Mid-Energy PRIMUS PRIMUS HI ONCOR Impression ONCOR Impression Plus ONCOR Avant Garde ONCOR Expression ARTISTE, ONCOR, and PRIMUS running the following: Control Console from software version 13.0.302 and higher; Control Console from software version 9.2.400 and higher; and Control Console from software version 11.0.400 and higher.
Z-1204-2019
Product summary
- Event
- Event 82605
- Status
- Terminated
- Classification
- Class II
- Quantity
- 120 US units
- Official record key
device-enforcement:Z-1204-2019
Official wording
Reason: Advisory issued not to disable or bypass the AMP function. Disabling or bypassing the AMP function for reasons of comfort is not advisable may lead to patient or user injury due to collision with LINAC equipment disabling the Auto Field Sequence (AFS) Automatic Motion Protection (AMP) function implemented at the control of the Digital Linear Accelerator.
Code information: SIEMENS Digital Linear Accelerators of type ARTISTE", ONCOR" and PRIMUS" running: - Control Console from software version 13.0.302 and higher - Control Console from software version 9.2.400 and higher - Controle Console from software version 11.0.400 and higher
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Advisory issued not to disable or bypass the AMP function. Disabling or bypassing the AMP function for reasons of comfort is not advisable may lead to patient or user injury due to collision with LINAC equipment disabling the Auto Field Sequence (AFS) Automatic Motion Protection (AMP) function implemented at the control of the Digital Linear Accelerator.