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.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1846-2021%22
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