Z-2146-2014Class II

ExacTrac is intended to be used to place patients at an accurately defined point within the treatment beam of...

Name: Z-2146-2014 ExacTrac is intended to be used to place patients at an accurately defined point within the treatment beam of...
Creator: Brainlab AG
Published: 2014-06-24
License: https://open.fda.gov/license/

Brainlab, Inc. / initiated 2014-06-24 / Terminated / root cause: software

FDA source

Brainlab AG began a recall of ExacTrac is intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic... on 2014-06-24. FDA classified it as Class II and gives the reason as "When using multiple isocenters (radiation treatment targets) within a single plan, in certain workflow conditions ExacTrac v.6.0.4 might move the patient to an unintended isocenter position, despite displaying the green...". 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-2146-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-24
Posted: 2014-08-04
Terminated: 2017-04-24
Recalling firm: Brainlab, Inc.
Product: ExacTrac is intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, in order to treat lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. ExacTrac may also be used to monitor the patient position during the treatment.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: When using multiple isocenters (radiation treatment targets) within a single plan, in certain workflow conditions ExacTrac v.6.0.4 might move the patient to an unintended isocenter position, despite displaying the green "OK" icon. If this anomaly occurs and is not detected by the user, the radiation treatment dose at the linear accelerator may be delivered to the unintended target position.
Root cause tag: software
FDA root cause: Software design
Action: Brainlab sent a FIELD SAFETY NOTICE / PRODUCT NOTIFICATION letter dated June 24, 2014, to all affected customers. The letter included instructions for customers to: 1) Avoid using plans with multiple isocenters in ExacTrac 6.0.4 whenever possible, and 2) If plans with multiple isocenters cannot be avoided and such a plan is used in ExacTrac v.6.0.4, then always select "Yes" in the dialog displayed to "keep the previous correction shift" when switching between isocenters and always verify all final treatment positions. Brainlab will provide a software update with this issue solved to affected customers. Brainlab will actively contact you to schedule the update within the next 6 months. Customers with questions can contact Brainlab at 800-597-5911 or via e-mail at [email protected].
Quantity in commerce: 15 systems
Distribution: Worldwide Distribution - USA including CA, CT, and IL; Internationally to France, Germany, Japan, Netherlands, Russia, and Slovenia.
Product codes and lots: ExacTrac Version 6.0.4; Model/Catalog Numbers: 1) 20833C EXACTRAC 6.0 IR POSITIONING SOFTWARE; 2) 20834C EXACTRAC 6.0 X-RAY POSITIONING SOFTWARE; 3) 20835C EXACTRAC 6.0 IR MONITORING SOFTWARE; 4) 20853C EXACTRAC 6.0 X-RAY LIMITED SOFTWARE; 5) 49926B ET UPGRADE SOFTWARE 3.X TO 6.0 (IR+XR); 6) 49927B ET UPGRADE SOFTWARE 4.X TO 6.0 (IR+XR); 7) 49928B ET UPGRADE SOFTWARE 5.X TO 6.0 (IR+XR); 8) 49933B ET UPGRADE TRUEBEAM 5.5 TO 6.0 LIMITED; 9) 49934A EXACTRAC UPGRADE 5.5 TO 6.0 BASIC; 10) 49936A ET SOFTWARE UPDATE 6.0.X TO 6.0.4; 11) 49938 ET SOFTWARE UPDATE 6.0.3TO 6.0.4; 12) 49939 ET SOFTWARE UPDATE 6.0.X to 6.0.4 P&R; 13) 49973B ET DATA PREP / REVIEW SYSTEM; 14) 49996B ET UPGRADE SOFTWARE X.X TO 6.0 SW ONLY; 15) 49997B ET UPGRADE SOFTWARE 5.5 TO 6.0 LIMITED; 16) 49998B ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2146-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2146-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-13	2014-08-04

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)