Important Safety Alerts

Medical device manufacturer, Brainlab AG, has issued a field safety notice concerning the iPlan RT version 4.0 and 4.1 (including all subversions: 4.0, 4.1.0, 4.1.1, 4.1.2, 4.1.3).

According to the manufacturer, iPlan RT Dose version 4.0 and 4.1 might not correctly refresh the dose calculation after certain multileaf collimator (MLC) shape modifications (see below) if all of the following conditions are met:

1. The modifications are performed for a Dynamic Conformal Arc, and
2. The jaw positions are defined manually, and
3. The dose display (e.g. isodose lines) is turned on, or if the dose has already been calculated and the dose display is turned on again after the MLC shape was modified.

The effect may occur for the following modifications of the MLC shape:

• The MLC margin of the arc is modified, or
• The MLC shape is modified in the beam's eye view (BEV) in a way that also changes the MLC shapes of neighboring segments of the arc1, or
• The Leaf Adaption is modified (Inline/Average/Outline), or
• The modified MLC shapes in the BEV are reset.

The dose calculation is not refreshed in the Physician's Review and Physicist's Verification tasks or when generating the printout or exporting the plan.

If the incorrect dose calculation is not recognized by the user, the actual delivered treatment dose might be different from the one shown in the treatment plan. If the plan is used for treatment and the deviation exceeds clinically acceptable limits, this could result in serious patient injury and/or ineffective treatment.

The manufacturer advises users to follow the user corrective actions as mentioned in the field safety notice. They also reminds users to continue to always follow the instructions and warnings as described in the iPlan RT Dose User Guide, in particular: "All information input to the iPlan RT Dose system and all information received from the iPlan RT Dose system as output must be reviewed regarding its plausibility before patient treatment.". In addition, the manufacturer will provide a software update with this issue solved to affected customers.

According to the local supplier, the affected devices were distributed in Hong Kong.

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 15 April 2013