ExacTrac 6.0 is a patient positioning and monitoring system recallZ-1513-2014 · Brainlab AG · initiated Feb 24, 2014
Class II Terminated All recalls posted in April 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Brainlab AG or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Software design
What the company is doing
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].
Recall details
- Recall number
- Z-1513-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Feb 24, 2014
- Posted by the FDA
- Apr 25, 2014
- Recalling firm
- Brainlab AG
- Quantity
- 41 systems (13 systems in US; 28 systems to foreign countries)
- Product code
- IYE
- FDA submissions
- K120789
- 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 description
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
Code information (models, lots, serial numbers)
ExacTrac version v.6.0.3.
Other devices under the same FDA submission
2 devices cleared under K120789 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Exactrac 6.2Brainlab SE · Accelerator, Linear, Medical1 recall6 reports
- Exactrac 6.5Brainlab SE · Accelerator, Linear, Medical1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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