Safety Alert for LINEAR ACCELERATORS CLINAC - Models: Clinac IX; Novalis; Unique; Trilogy; Clinac Linear Radiotherapy Accelerator; Linear High Energy Radiotherapy Accelerator Clinac. Anvisa Registry: 10405410012; 10405410016; 10405410020; 10405410011; 10405410001; and 10405410010. Models that have Clinac software prior to version 7, which do not use a secondary system to read the position of the collimator and treatment table.

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

Anomalies have been identified in the Clinac collimator and in the treatment tables, which may adversely affect high dose treatments requiring small positioning tolerances, such as stereotactic radiosurgery and radiotherapy (SRS and SRT) treatments. This anomaly only affects Clinac devices of an older generation with Clinac software prior to version 7, which do not use a secondary system to read the position of the collimator and treatment table. Collimator Angle Errors: If the current that positions the collimator skips one or more teeth from the potentiometer gear used to position the collimator (each tooth of the gear corresponds to about 1.5 degrees of rotation of the collimator), the cumulative deviation from the angle of the collimator may exceed 5 degrees. Positioning of the table: Varian has identified an anomaly in which the belt used to position the table's longitudinal movable structure may loosen, causing an incorrect longitudinal positioning of the table that can reach up to 2.5 millimeters. Deviation from the table position is more likely to have significant clinical effects on SRS and SRT treatments requiring small positioning tolerances. Varian has identified this anomaly by an internal test and is not aware that it has occurred in the clinical settings of an institution. Varian also learned that, when performing SRS or SRT treatments, unlike most, some users do not use third-party systems for patient placement, intended to perform submillimetric positioning in this type of treatment. Alternatively, when a difference occurs between a third-party positioning system and Varian's remote positioning coordinates, some users choose to use Varian's coordinates over those of the other positioning system. Varian tables offer a positioning resolution of 1 mm and are generally less accurate than those of other positioning systems for SRS / SRT treatments. Varian strongly advises customers to follow the recommendations of the AAPM Report No. 54, Stereotactic Radiosurgery1, which recommends the use of such a positioning and quality control system. They may adversely affect high dose treatments requiring small positioning tolerances, such as stereotactic radiosurgery and radiotherapy (SRS and SRT) treatments. For conventional treatments, the risk is diminished because they are effected in several days at relatively smaller doses. The use of a positioning system appropriate to SRS and SRT treatments and daily positioning verification reduces or eliminates these risks.