FDA Device recall Z-1185-2021
ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System)
- FDA Device
- Class II
- terminated
- Published 2021-03-17
On 2021-03-17 the FDA classified a Class II recall of ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System) by Brainlab Ag, citing in case of a failed automatic marker detection, a software error causes parts of the display to incorrectly behave as if the current patient position is within predefined toleranc….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1185-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-03-01 |
| Published | 2021-03-17 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Brainlab Ag |
| Distribution | AR, AZ, CA, IN, NC, NJ, NY, OR |
Product
ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System).
Reason
In case of a failed automatic marker detection, a software error causes parts of the display to incorrectly behave as if the current patient position is within predefined tolerances and may allow the user to proceed to treatment despite potentially exceeding shift values.
Identifiers
| code_info | Model/catalogue numbers: 20910-06 ETD Implanted lic. UDI: The GTIN for ExacTrac Dynamic version 1.0 is 04056481142315.…Model/catalogue numbers: 20910-06 ETD Implanted lic. UDI: The GTIN for ExacTrac Dynamic version 1.0 is 04056481142315. GMDN code: 40887. Software revisions of affected ExacTrac Dynamic software: versions 1.0.0, 1.0.1, 1.0.2. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Other recalls by Brainlab Ag
- Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1
FDA Device · Class II · 2025-03-26 · Brainlab Ag - Cirq Arm System 2.0
FDA Device · Class II · 2023-04-05 · Brainlab Ag - Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F
FDA Device · Class II · 2023-03-22 · Brainlab Ag - ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INST
FDA Device · Class II · 2022-03-16 · Brainlab Ag - ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 - Product Usage: intended to position patients at…
FDA Device · Class II · 2021-06-16 · Brainlab Ag
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1185-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.