Company: Brainlab AG.
Date of Enforcement Report: 8/13/2014
Class lI:
PRODUCT
ExacTrac is intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, in order to treat lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. ExacTrac may also be used to monitor the patient position during the treatment. Recall Number Z-2146-2014
REASON
When using multiple isocenters (radiation treatment targets) within a single plan, in certain workflow conditions ExacTrac v.6.0.4 might move the patient to an unintended isocenter position, despite displaying the green “OK” icon. If this anomaly occurs and is not detected by the user, the radiation treatment dose at the linear accelerator may be delivered to the unintended target position..
RECALLING FIRM/MANUFACTURER
Brainlab AG , Feldkirchen, DE on 6/24/2014 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
15 systems
DISTRIBUTION
Nationwide and Internationally
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