Important Safety Alerts

Medical device manufacturer, Brainlab AG has issued a medical device safety alert concerning the all subversions of the iPlan 3.0 as follows:-

• iPlan CMF 3.0
• iPlan Cranial 3.0
• iPlan ENT 3.0, iPlan Flow 3.0
• iPlan Spine 3.0
• iPlan Stereotaxy 3.0

According to the manufacturer, when exporting a treatment plan created with Brainlab iPlan 3.0 for usage with Brainlab Navigation Software, planned objects may not be correctly displayed in the Navigation Software if all of the following conditions are met:

1. Standard Brainlab Format is used. That means the plan is exported to one of the following Navigation Software versions:
   • VectorVision Cranial/ENT, version 7.x
   • Kolibri Cranial/ENT, version 2.x
   • Cranial/ENT Essential/Unlimited, version 1.x
   • VectorVision Spine, version 5.5.1
   • VectorVision Spine, version 5.6
2. One or more slices of the image set – or of any image set that is fused to it – exceeds in any direction (x/y/z) a coordinate of +511 mm or -511 mm, and the contours of the planned object extend into those slices.
3. The standard export settings have been changed:
   • The feature "Enable interpolation for non-512x512 images" is disabled. By default this feature is enabled for every user login/account.

In case all of the above mentioned conditions are met, the planned objects may be shown cropped, the boundaries may be shaped differently or the objects may appear larger or smaller in the Navigation System than originally planned.

If the potentially incorrect object shape is not detected by the user during review of the imported plan, and the object is used within surgery performed with the aid of a Brainlab Navigation System, the information displayed could potentially mislead the surgeon, ultimately leading to ineffective treatment, serious injury or even death of the patient.

The manufacturer advised that the affected users shall adhere to the following:

• When exporting from iPlan to Standard Brainlab Format ensure that in the Settings the checkbox "Enable interpolation for non-512x512 images" is checked.
• This has to be ensured separately for each of the iPlan versions. (e.g. for iPlan Cranial and iPlan ENT)
• When using the software with iPlan Net, the corrective action has to be performed for every user login/account.

Brainlab will provide a software update with this issue solved to the affected customers.

According to the manufacturer, the affected products were distributed in Hong Kong.

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

Posted on 05 July 2013