Medical device manufacturer, Varian, has issued an urgent medical device correction concerning OBI 1.3, OBI 1.4; OBI 1.5; TrueBeam 1.0; Offline Review 1.0 - 2.0.
An anomaly has been identified in the 3D Match environment of OBI 1.3, OBI 1.4, OBI 1.5, TrueBeam 1.0 and Offline Review 1.0 – 2.0 when using reference CT datasets which contain a critical number of slices. When these reference CT datasets are used to create a reference CT volume in the 3D Match environment, in a small number of cases, the scaling of the CT volume will be incorrect and the CT volume will appear larger – in the slice direction - than it actually should be. If this improperly scaled CT volume is used for 3D matching, the CBCT volume and patient may be positioned too far superiorly.
According to the local supplier, the affected device has been distributed in Hong Kong. Varian has notified all possibly affected customers and developing a correction for this issue.
If you are in possession of the affected products, please contact supplier for necessary actions.