FDA Device recall Z-1259-2023
Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F
- FDA Device
- Class II
- ongoing
- Published 2023-03-22
On 2023-03-22 the FDA classified a Class II recall of Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F by Brainlab Ag, citing deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a standard-workflow Treatment Template.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1259-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-02-14 |
| Published | 2023-03-22 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Brainlab Ag |
| Distribution | US |
Product
Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F.
Reason
Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a standard-workflow Treatment Template
Identifiers
| code_info | Versions 1.1.0 and 1.1.1, GTIN: 04056481143978. |
|---|
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-1259-2023%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.