ExacTrac versions 6.5 through 6.5 intended to be used to place patients at an accurately defined point within…
Medical device recall Z-1006-2018. Published in FDA’s Enforcement Report on Mar 21, 2018.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Mar 21, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Not named no state, in where it went
- 587 systems how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
The usage of workflows that deviate from the recommended specifications in the User manual for ExacTrac Patient Positioning System (versions 6.0, 6.1, 6.2, 6.5) with Auxiliary Device Interface (ADI) and Varian Clinac or Varian TrueBeam, which may result in misinterpretation of beam authorization via ADI.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
ExacTrac versions 6.5 through 6.5 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.
587 systems, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI: GTIN for ExacTrac 6.0 and 6.1 is not applicable GTIN for ExacTrac 6.2 is: 04056481000264 GTIN for ExacTrac 6.5 is: 04056481138400 License No. Description 20833 EXACTRAC 6.0 IR POSITIONING SOFTWARE 20834 EXACTRAC 6.0 X-RAY POSITIONING…
Every code shown here, 1,996 characters
UDI: GTIN for ExacTrac 6.0 and 6.1 is not applicable GTIN for ExacTrac 6.2 is: 04056481000264 GTIN for ExacTrac 6.5 is: 04056481138400 License No. Description 20833 EXACTRAC 6.0 IR POSITIONING SOFTWARE 20834 EXACTRAC 6.0 X-RAY POSITIONING SOFTWARE 20835 EXACTRAC 6.0 IR MONITORING SOFTWARE 20853 EXACTRAC 6.0 X-RAY LIMITED SOFTWARE 20871 EXACTRAC 6.1 X-RAY POSITIONING SOFTWARE 20872 EXACTRAC 6.1 IR POSITIONING SOFTWARE 20873 EXACTRAC 6.1 X-RAY MONITORING SOFTWARE 20874 EXACTRAC 6.1 X-RAY LIMITED SOFTWARE 20881 EXACTRAC 6.2 X-RAY POSITIONING SOFTWARE 20884 EXACTRAC 6.2 X-RAY LIMITED SOFTWARE 20833A EXACTRAC 6.0 IR POSITIONING SOFTWARE 20833B EXACTRAC 6.0 IR POSITIONING SOFTWARE 20833C EXACTRAC 6.0 IR POSITIONING SOFTWARE 20833D EXACTRAC 6.0 IR POSITIONING SOFTWARE 20833E EXACTRAC 6.0 IR POSITIONING SOFTWARE 20834A EXACTRAC 6.0 X-RAY POSITIONING SOFTWARE 20834B EXACTRAC 6.0 X-RAY POSITIONING SOFTWARE 20834C EXACTRAC 6.0 X-RAY POSITIONING SOFTWARE 20834D EXACTRAC 6.0 X-RAY POSITIONING SOFTWARE 20834E EXACTRAC 6.0 X-RAY POSITIONING SOFTWARE 20835A EXACTRAC 6.0 IR MONITORING SOFTWARE 20835B EXACTRAC 6.0 IR MONITORING SOFTWARE 20835C EXACTRAC 6.0 IR MONITORING SOFTWARE 20835D EXACTRAC 6.0 IR MONITORING SOFTWARE 20835E EXACTRAC 6.0 IR MONITORING SOFTWARE 20853A EXACTRAC 6.0 X-RAY LIMITED SOFTWARE 20853B EXACTRAC 6.0 X-RAY LIMITED SOFTWARE 20853C EXACTRAC 6.0 X-RAY LIMITED SOFTWARE 20853D EXACTRAC 6.0 X-RAY LIMITED SOFTWARE 20853E EXACTRAC 6.0 X-RAY LIMITED SOFTWARE 20871A EXACTRAC 6.1 X-RAY POSITIONING SOFTWARE 20872A EXACTRAC 6.1 IR POSITIONING SOFTWARE 20873A EXACTRAC 6.1 X-RAY MONITORING SOFTWARE 20874A EXACTRAC 6.1 X-RAY LIMITED SOFTWARE 20881A EXACTRAC 6.5 X-RAY POSITIONING SOFTWARE 20882-02 EXACTRAC 6.2.0 SW LICENSE 20882-02A EXACTRAC 6.2.1 SW LICENSE 20882-02B EXACTRAC 6.5.0 SW LICENSE 20883-02A EXACTRAC 6.2 X-RAY MONITORING SOFTWARE 20883-02B EXACTRAC 6.5 X-RAY MONITORING SOFTWARE 20836 EXACTRAC 6.X VARIAN CBCT LICENSE 20838 EXACTRAC 6.X X-RAY MONITORING LICENSE…
FDA’s list runs to 5,831 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
worldwide
These words name no state.
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Feb 14, 2018.
- FDA classified it on Mar 14, 2018.
- FDA’s Enforcement Report published it on Mar 21, 2018.
- FDA terminated it on May 17, 2021.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Brainlab AG, of Munich, Germany.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: E-Mail.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 5,831 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.