Company:Brainlab AG
Date of Enforcement Report: 4/1/2015
Class lI:

PRODUCT

ExacTrac versions 6.x patient positioning systems are used to position patients during radiosurgery or radiotherapy procedures..
Recall Number Z-1316-2015

REASON
The ExacTrac 6.x Patient Positioning System may incorrectly position the patient when using the ExacTrac Cone Beam CT (CBCT) with a TrueBeam-specific optional subvolume-CBCT..

RECALLING FIRM/MANUFACTURER
Brainlab AG, Feldkirchen, DE on 2/16/2015 Voluntary: Firm Initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
24 systems (US); 36 systems (Foreign)

DISTRIBUTION
Nationwide and Internationally

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