550 TxT Treatment Table used with PRIMUS, ONCOR and ARTISTE Digital Linear Accelerators (LINAC) 의 리콜

Recall

RC-2014-RN-00455-1

Class I

2014-04-17

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00455-1

The following safety issues have been identified with the 550 txt treatment table :1. in very rare instances, the actual table position may significantly deviate from the position at the table side control and the linac control console, but no interlock occurs.2. in sporadic cases the following issue for the table axis lateral, longitudinal and isocentric rotation occurs: after a manual table movement with released brake an immediate automatic movement for the same table axis is not possible.

Siemens has developed a new version of the 550 TxT Treatment Table software. In addition to the software update, Siemens is providing 550 TxT Treatment Table Addendum for the IFU that describes new table error codes. The software update will prevent the failure mode by the following actions: 1. A plausibility check was introduced for comparing the two independent encoder systems of each table axis. 2. The time between two encoder comparisons was reduced to 50ms and an error code was introduced.