Brainlab AG Ammerthalstrasse 8 Kirchheim B. Muenchen Germany BrainLAB Target Positioner for Leksell Headring used with the iPlan RT Dose (versions 3.0, 3.0.1 and 3.0.2) and BrainSCAN (version 5.31) Radiotherapy Treatment Planning Software, ; BrainLab AG, Ammerthalstrasse 8, 85551 Heimstetten, Germany; catalog/version number 40700-3A Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Target Alignment Error : A mechanical component/software incompatibility caused by a specific combination of the BrainLAB Target Positioner version 40700-3A for Leksell headrings and BrainLAB planning software resulted in a 1.25 mm shift in target area alignment during radiosurgery treatment.

Recommended Action

Per FDA guidance

BrainLAB immediately notified all customers with the BrainSCAN or iPlan RT Dose software in combination with the BrainLAB Target Positioner for Leksell Headring, via e-mail on June 5, 2007. The Urgent Medical Device Product Notification letter dated June 4, 2007 included in the e-mail informed the customers that both the BrainSCAN and iPlan RT Dose treatment planning software calculates the isocenter position printed on the Target Positioner Overlays shifted 1.25 mm in cranial direction from the intended position, when the BrainLAB Target Positioner for Leksell Headring Revision A is used. The customers were instructed to cease using the BrainSCAN or iPlan RT Dose software in combination with the BrainLAB Target Positioner for Leksell Headring for treatment planning and patient set-up. An updated target positioner will be provided to the customers to correct the problem, estimated to be available in September 2007. Any questions were directed to their local BrainLAB Customer Support Representative or CAPA Manager Markus Hofman at 49-89-99-15-68-44 or 1-800-597-5911 in the U.S.

Distribution

As reported by FDA

OH, WA