Company:Brainlab AG
Date of Enforcement Report: 5/13/2015
Class lI:
PRODUCT
ExacTrac 6.x. is software used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures. Recall Number Z-1582-2015
REASON
ExacTrac 6.x Patient Positioning System: Potentially incorrect patient positioning when using the ExacTrac Cone Beam CT (CBCT) with a CBCT acquired at a couch angle other than 0.0 degrees.
RECALLING FIRM/MANUFACTURER
Brainlab AG, Feldkirchen, DE on 3/6/2015 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
26 systems
DISTRIBUTION
Nationwide and Internationally
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