Z-1707-2014Class II

ExacTrac 5.5, an Image Processing System used for patient positioning for radiation therapy or radiosurgery

Name: Z-1707-2014 ExacTrac 5.5, an Image Processing System used for patient positioning for radiation therapy or radiosurgery
Creator: Brainlab AG
Published: 2014-04-15
License: https://open.fda.gov/license/

Brainlab, Inc. / initiated 2014-04-15 / Terminated / root cause: software

FDA source

Brainlab AG began a recall of ExacTrac 5.5, an Image Processing System used for patient positioning for radiation therapy or radiosurgery on 2014-04-15. FDA classified it as Class II and gives the reason as "When using a specific plan update workflow in combination with a non-Brainlab treatment planning system (TPS), there is a possibility in ExacTrac 5.5.5 to generate an unintended blend of two initially separate plans of...". 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-1707-2014
Classification: Class II
Status: Terminated
Initiated: 2014-04-15
Posted: 2014-06-03
Terminated: 2017-04-24
Recalling firm: Brainlab, Inc.
Product: ExacTrac 5.5, an Image Processing System used for patient positioning for radiation therapy or radiosurgery.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: When using a specific plan update workflow in combination with a non-Brainlab treatment planning system (TPS), there is a possibility in ExacTrac 5.5.5 to generate an unintended blend of two initially separate plans of the same patient.
Root cause tag: software
FDA root cause: Software design
Action: Brainlab sent a "FIELD SAFETY NOTICE / PRODUCT NOTIFICATION" letter dated March 13, 2014 was sent to all affected customers. The letter identifies the affected product, problem, and actions to be taken. The letter includes specific instructions to users that are intended to reduce the likelihood of similar events occurring when using ExacTrac software version 5.5.5. The letter further states that Brainlab will be providing a software update to all customers. Brainlab will contact all customers to arrange for the software update within the following 6 months. Customers with any questions about this issue can contact Brainlab at 800-597-5911 or via e-mail at [email protected].
Quantity in commerce: 40 systems (worldwide)
Distribution: Worldwide Distribution - US Nationwide in the states of AZ, AR, CA, FL, KY, MA, NE, NY, TN, TX and the countries of Argentina, Australia, Brazil, Finland, India, Japan, Netherlands, Oman, Russia, and Taiwan
Product codes and lots: ExacTrac software version 5.5.5 is included in the following model / catalog numbers: 1) 20818B ET SOFTWARE 5.5.5; 2) 20820 ET SOFTWARE UPDATE 5.0 TO 5.5; 3) 49905D EXACTRAC COMPLETE SYSTEM UPG 3.X TO 5.5; 4) 49908C EXACTRAC SOFTWARE UPGRADE 3.X TO 5.5; 5) 49909A EXACTRAC SOFTWARE UPGRADE 4.X TO 5.5; 6) 49918 ET SOFTWARE UPDATE 5.5.X TO 5.5.5; 7) 49919 ET SOFTWARE UPDATE 5.0.X TO 5.5.5; 8) 49660A ET INFRARED SOFTWARE 5.5.5; 9) 49961 ET DATA PREP/REVIEW SYSTEM; 10) 49986 ET SYSTEM UPGRADE 3.X TO 5.5 NEW VAULT; 11) 49987 ET SYSTEM UPGRADE 4.X TO 5.5 NEW VAULT; 12) 49988 ET SYSTEM UPGRADE 4.X TO 5.5 SAME VAULT; 13) 49989 ET SYSTEM UPGRADE 5.0 TO 5.5 NEW VAULT; 14) 49990 ET SYSTEM UPGRADE 5.0 TO 5.5 SAME VAULT; 15) 49991 ET SYSTEM UPGRADE 5.5 TO 5.5 NEW VAULT

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1707-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1707-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-11	2014-06-03

Product code IYE

K072506Class IIExactrac 5.5Brainlab AG / cleared 2007-10-26

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)