Safety Alert for SURGICAL / CLINICAL PLANNING SOFTWARE iPLAN BRAINLAB. Model: iPlan RT Dose. Registro Anvisa n ° 80042070008. Affected versions: iPlan RT Dose version 4.0 and 4.1 (including all subversions).

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.

Brainlab's research has shown that the iPlan RT Dose version 4.0 and 4.1 may not update the dose calculation correctly after certain modifications of the MLC form (see below) if all of the following conditions have been met: 1. Modifications are performed for one Dynamic Conformational Arc; and 2. The positions of the collimators are set manually, and 3. The dose display (e.g., isodose lines) is attached, or if the dose has already been calculated and the dose display was reconnected after the form of the MLC has been modified. The effect may occur for the following MLC shape modifications: - The arc MLC margin has been modified; or - The shape of the MLC was modified in the projected beam perspective view (BEV) in a way that also modifies the MLC forms of neighboring segments of arc1; or - Blade adaptation is modified (Inline / Average / Outline); or - Modified forms of MLC in BEV are restored. Dose calculation is not updated in the Physician Review and Physicist Verification tasks or when generating the impression or exporting the plan. If the calculation of the incorrect dose is not recognized by the user, the actual applied dose of treatment may be different from that shown in the treatment plan. If the plan is used for treatment and the deviation exceeds acceptable clinical limits, the patient's health risk can not be disregarded. Brainlab Ltda has already started the corrective field action in Brazil and, according to the last monitoring report presented, has already finalized the communication to the clients involved. The reference code for the company's field action is CAPA-20130328-000289.