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.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0733-2022%22
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