Z-1513-2014Class II

ExacTrac 6.0 is a patient positioning and monitoring system. Model/catalogue numbers: 20833B EXACTRAC 6.0 IR...

Name: Z-1513-2014 ExacTrac 6.0 is a patient positioning and monitoring system. Model/catalogue numbers: 20833B EXACTRAC 6.0 IR...
Creator: Brainlab AG
Published: 2014-02-24
License: https://open.fda.gov/license/

Brainlab, Inc. / initiated 2014-02-24 / Terminated / root cause: software

FDA source

Brainlab AG began a recall of ExacTrac 6.0 is a patient positioning and monitoring system. Model/catalogue numbers: 20833B EXACTRAC 6.0 IR POSITIONING SOFTWARE 49936 ET SOFTWARE UPDATE... on 2014-02-24. FDA classified it as Class II and gives the reason as "When using multiple radiation treatment targets within a single plan, the ExacTrac v.6.0.3 might position the patient to an unintended radiation treatment point. As a result, there is a possibility that the radiation...". 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-1513-2014
Classification: Class II
Status: Terminated
Initiated: 2014-02-24
Posted: 2014-04-25
Terminated: 2017-04-24
Recalling firm: Brainlab, Inc.
Product: ExacTrac 6.0 is a patient positioning and monitoring system. Model/catalogue numbers: 20833B EXACTRAC 6.0 IR POSITIONING SOFTWARE 49936 ET SOFTWARE UPDATE 6.0.X TO 6.0.3 49926B ET UPGRADE SOFTWARE 3.X TO 6.0 (IR+XR) 49934A EXACTRAC UPGRADE 5.5 TO 6.0 BASIC 49927B ET UPGRADE SOFTWARE 4.X TO 6.0 (IR+XR) 49928B ET UPGRADE SOFTWARE 5.X TO 6.0 (IR+XR) 49933B ET UPGRADE TRUEBEAM 5.5 TO 6.0 LIMITED 49973B ET DATA PREP / REVIEW SYSTEM 49998B ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT 49996B ET UPGRADE SOFTWARE X.X TO 6.0 SW ONLY 49997B ET UPGRADE SOFTWARE 5.5 TO 6.0 LIMITED
Product code: IYE Accelerator, Linear, Medical
Reason for recall: When using multiple radiation treatment targets within a single plan, the ExacTrac v.6.0.3 might position the patient to an unintended radiation treatment point. As a result, there is a possibility that the radiation treatment dose may be delivered to the unintended target position.
Root cause tag: software
FDA root cause: Software design
Action: A FIELD SAFETY NOTICE / PRODUCT INFORMATION letters, dated February 24, 2014, were sent to all direct accounts. The letter identified the affected product, the reason for the recall, and included instructions for direct accounts to take while a permanent fix can be deployed. The letter also advised that a software update will be made available starting the end of April 2014. Customers with questions or concerns can contact Brainlab at 800-597-5911 or via e-mail at [email protected].
Quantity in commerce: 41 systems (13 systems in US; 28 systems to foreign countries)
Distribution: Worldwide Distribution -- USA, including the states of CA, IN, LA, MA, OH, TX, and WI, and the countries of Australia, China, France, Germany, Japan, Netherlands, and the United Kingdom.
Product codes and lots: ExacTrac version v.6.0.3.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1513-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1513-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-07	2014-04-25

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)