FDA Device recall Z-0733-2022
ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INST
- FDA Device
- Class II
- ongoing
- Published 2022-03-16
On 2022-03-16 the FDA classified a Class II recall of ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INST by Brainlab Ag, citing the yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0733-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-02-25 |
| Published | 2022-03-16 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Brainlab Ag |
| Distribution | AR, AZ, CA, CO, FL, GA, IN, KY, MD, MO, MS, NC, NJ, NY, OK, OR, PA, TX, VA, WA |
Product
ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INST; 20910-01A, ETD Positioning and Moni. 1.0.1 INST; 20910-01B, ETD Positioning and Moni. 1.0.2 INST; and 20910-01C ETD Positioning and Moni. 1.0.3 INST.
Reason
The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs.
Identifiers
| code_info | Software versions 1.0.0, 1.0.1, 1.0.2, 1.0.3, GTIN 04056481142315. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
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 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 - ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System)
FDA Device · Class II · 2021-03-17 · Brainlab Ag
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0733-2022%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.