LINEAR DIGITAL ARTISTE ACCELERATOR, Registration 10234230172 - Serial Numbers: 5746; 5828 의 안전성 경고

Safety alert

1691

2015-09-19

Brazil

ANVISA

http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp

Siemens announces that the syngo rt therapisttm software version and the control console software have been updated to address the following safety issues: - automatic movement prevention in the event of a significant risk of collision; - repositioning of 160 mlc after the motion stop block; - restarting the command console; - support of fractional monitor units for virtual wedge; - loss of information after the change of the uid of the plan in the information system on cancer (ois); - calculation of incorrect automatic deviation in combination with images acquired with ctvision; - calculation of incorrect deviation in the adaptive targeting option; - interruption of the reconstruction of the cone beam; - table rotation values ​​for relative setup; - resumes during the wrong session in the case of 0 (zero) managed monitor units; - unintended movement of the table after the internal error message in the syngo rt therapist; - dose linearity quality control procedure for the imrt (physics primer user documentation update); - automatic sequence setup for bolus fields; - workflow information to change the patient for treatment from one digital linear accelerator to another. the corrective measures described in this field safety information affect the syngo rt therapisttm combination and the control console. both upgrades must be performed at the same time to ensure proper system operation.

The company guides the custody of the Portuguese Charter of this field action together with the Owner's Manual of the Linear Accelerator System for any queries.