Company:Brainlab AG
Date of Enforcement Report:7/11/2007
Class:ll

PRODUCT
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, ; catalog/version number 40700-3A, Recall # Z-1010-2007

REASON
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.

CODE
All serial numbers

RECALLING FIRM/MANUFACTURER
Brainlab AG, Kirchheim B. Muenchen, Germany, by letter dated June 4, 2007 and by e-mail on June 5, 2007. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
7 units

DISTRIBUTION
OH, WA, and France