ExacTrac Dynamic software — Class II medical device recall Z-1846-2021
Terminated recall by Brainlab AG, reported 2021-06-16, distributed nationwide. Display of potential patient movement might be delayed to the user for high dose treatments.
| Recall number | Z-1846-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Brainlab AG, Munich, N/A, Germany |
| Recall initiated | 2021-05-14 |
| Classified | 2021-06-10 |
| Reported by FDA | 2021-06-16 |
| Terminated | 2023-03-20 |
| Distributed | Nationwide (US) |
| Quantity | 22 systems |
| UPC / GTIN / UDI-DI | 04056481142315 |
| Model numbers | 20910-01BETD |
Product
ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 - Product Usage: intended to position patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, to monitor the patient position, and to provide a beam hold signal in case of a deviations in order to treat lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
Reason for recall
Display of potential patient movement might be delayed to the user for high dose treatments.
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-1846-2021. 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.