Z-1316-2015Class II

ExacTrac versions 6.x patient positioning systems are used to position patients during radiosurgery or...

Name: Z-1316-2015 ExacTrac versions 6.x patient positioning systems are used to position patients during radiosurgery or...
Creator: Brainlab AG
Published: 2015-02-16
License: https://open.fda.gov/license/

Brainlab, Inc. / initiated 2015-02-16 / Terminated / root cause: software

FDA source

Brainlab AG began a recall of ExacTrac versions 6.x patient positioning systems are used to position patients during radiosurgery or radiotherapy procedures on 2015-02-16. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1316-2015
Classification: Class II
Status: Terminated
Initiated: 2015-02-16
Posted: 2015-03-25
Terminated: 2017-02-28
Recalling firm: Brainlab, Inc.
Product: ExacTrac versions 6.x patient positioning systems are used to position patients during radiosurgery or radiotherapy procedures..
Product code: IYE Accelerator, Linear, Medical
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software in the Use Environment
Action: BrainLab sent an FIELD SAFETY NOTICE / PRODUCT NOTIFICATION letters dated February 16, 2015, to all affected customers. The letters included instructions for customers to: 1) Do not use any actively re-reconstructed CBCT subvolumes from the Varian TrueBeam system with the Brainlab ExacTrac 6.x CBCT Import & Alignment Software module; 2) Import exclusively original, not modified, CBCT volumes into ExacTrac to use for patient positioning; and, 3) Continue to verify any ExacTrac CBCT-based correction using the ExacTrac X-ray verification and/or an external IGRT procedure as mandatory. Brainlab provided existing potentially affected ExacTrac v.6.x CBCT Import & Alignment Software customers (with a Varian TrueBeam system) with the product notification information. Brainlab will provide a software update with this issue solved to affected customers. Brainlab will actively contact the customer starting August 2015 to schedule the update installation. For further questions please call Customer Hotline + 49 89 99 15 68 44 or 1-800 597-5911 ( For US Customers only)
Quantity in commerce: 24 systems (US); 36 systems (Foreign)
Distribution: Worldwide Distribution - USA and to the countries of : Australia, Austria, Canada Denmark, France, Germany, Hong Kong, Japan, Russia, Singapore, South Korea and United Kingdom.
Product codes and lots: ExacTrac versions 6.x including versions 6.0.0, 6.0.1, 6.0.2, 6.0.3, 6.0.4, 6.0.5; and v. 6.1.0. Model/Catalog Numbers: 49971, CBCT IMPORT & ALIGNMENT SOFTWARE; 20836, EXACTRAC 6.0 VARIAN CBCT LICENSE; The software may be contained in configured items: 48320, ET UPGRADE SOFTWARE 6.0 TO 6.1; 48320-99, ET UPGRADE SOFTWARE 6.0 TO 6.1 SLA; 49973B, ET DATA PREP / REVIEW SYSTEM; 49973A, ET DATA PREP / REVIEW SYSTEM; 49973, ET DATA PREP / REVIEW SYSTEM; 49998B, ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT; 49998A, ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT; 49998, ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT; 48304, ET 6.1 DATA PREP/REVIEW SYSTEM UPG. KIT; 48302, ET DATA PREP / REVIEW SYSTEM

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1316-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1316-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-01	2015-03-25

Product code IYE

K120789Class IIExactrac X-Ray X-RayBrainlab AG / cleared 2012-08-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)