FDA Device recall Z-1846-2021
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
- terminated
- Published 2021-06-16
On 2021-06-16 the FDA classified a Class II recall of ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 - Product Usage: intended to position patients at… by Brainlab Ag, citing display of potential patient movement might be delayed to the user for high dose treatments.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1846-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-05-14 |
| Published | 2021-06-16 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Brainlab Ag |
| Distribution | US |
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
Display of potential patient movement might be delayed to the user for high dose treatments.
Identifiers
| code_info | Version 1.02, GTIN 04056481142315 |
|---|
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 (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-1846-2021%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.