ExacTrac Dynamic software model numbers: 20910-01 — Class II medical device recall Z-0733-2022
Ongoing recall by Brainlab AG, reported 2022-03-16, distributed in AR, AZ, CA, CO, FL, GA, IN, KY…. The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs.
| Recall number | Z-0733-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Brainlab AG, Munich, N/A, Germany |
| Recall initiated | 2022-02-25 |
| Classified | 2022-03-08 |
| Reported by FDA | 2022-03-16 |
| Distributed | AR, AZ, CA, CO, FL, GA, IN, KY, MD, MO, MS, NC, NJ, NY, OK, OR, PA, TX, VA, WA |
| Countries outside the US | AE, AT, AU, BE, BH, CN, DE, DK, ES, FR, GB, HK, IE, IL, IN, IT, JO, JP, KR, NZ, PL, SG, SK, TH, TR |
| Quantity | 205 systems |
| UPC / GTIN / UDI-DI | 04056481142315 |
| Model numbers | 20910-01 |
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 for recall
The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0733-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.