01
Apr
2015

Cl II BrainLab ExacTrac versions 6.x

0

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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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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