Company: BRainlab AG.
Date of Enforcement Report:6/11/2014
Class lI:
PRODUCT
ExacTrac 5.5, an Image Processing System used for patient positioning for radiation therapy or radiosurgery. Recall Number Z-1707-2014
REASON
When using a specific plan update workflow in combination with a non-Brainlab treatment planning system (TPS), there is a possibility in ExacTrac 5.5.5 to generate an unintended blend of two initially separate plans of the same patient.
RECALLING FIRM/MANUFACTURER
Brainlab AG , Feldkirchen, DE on 4/15/2014 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
40 systems
DISTRIBUTION
Nationwide and Internationally
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