Use cautionMedical device recall · FDA · Published May 14, 2021
Brainlab ExacTrac Dynamic Software Recall: Delayed Patient Movement Display Risk
Brainlab recalls ExacTrac Dynamic software version 1.0.2 for potential delayed patient movement display during high-dose radiation treatments. Affected units may require software update to prevent safety risks.
“Brainlab ExacTrac Dynamic Software Recall: Delayed Patient Movement Display Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62540-brainlab-exactrac-dynamic-software-recall-delayed-patient-movement-display-risk. Based on FDA recall #Z-1846-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1846-2021%22&limit=1).
Brainlab AG recalled ExacTrac Dynamic software on May 14, 2021, because potential patient movement displays might be delayed for high dose treatments, according to the FDA. The recall affects 22 systems distributed nationwide.
How to tell if you have it
ExacTrac Dynamic software
Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2
UPC 04056481142315
The hazard
The software is intended to position patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures. The hazard is that display of potential patient movement might be delayed to the user for high dose treatments.
Context
GovInfoNow's records show Brainlab AG has 15 other recalls on record since 2017-07-28. Other recent recalls include Brainlab Origin Data Management Software (2025-02-10), Brainlab Cirq Arm System 2.0 (2023-03-02), and Brainlab ExacTrac Software (2023-02-14). Similar recent recalls of positioning software include Hitachi Proton Beam Therapy System (2026-02-06) and Elekta Leksell GammaPlan 11.1 Software (2025-12-12).
How to tell if you have this one
Check if you have the ExacTrac Dynamic software version 1.0.2 with GTIN 04056481142315. The software is used for positioning patients during radiation treatments for tumors and other conditions.
Brand
Brainlab
Product
ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify your software version by checking the product documentation or the software interface.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 11 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of AZ, AR, CA, FL, IN, NJ, NY, NC, OR, PA, and TX. There was no government/military distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, Arkansas, California, Florida, Indiana, New Jersey, New York, North Carolina, Oregon, Pennsylvania, Texas.
Recall timeline
FDA terminated this recall 22 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1846-2021 (May 14, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1846-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.