FDA Device recall Z-0174-2022
Concerto User Interface Software provided with the following systems: (1) Xstrahl 100 Electronic Brachytherapy - 100kV Superficial X-Ray Th…
- FDA Device
- Class II
- terminated
- Published 2021-11-03
On 2021-11-03 the FDA classified a Class II recall of Concerto User Interface Software provided with the following systems: (1) Xstrahl 100 Electronic Brachytherapy - 100kV Superficial X-Ray Th… by Xstrahl, citing if a saved treatment plan with 2 opposing beams is edited prior to approval, then Beam 2 is not updated with the changed parameters upon selecting save, resulting in error message….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0174-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-04-26 |
| Published | 2021-11-03 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Xstrahl |
| Distribution | US |
Product
Concerto User Interface Software provided with the following systems: (1) Xstrahl 100 Electronic Brachytherapy - 100kV Superficial X-Ray Therapy System; (2) Xstrahl 150 Electronic Brachytherapy - 150kV Superficial X-Ray Therapy System; (3) Xstrahl 200 - 225kV Superficial / Orthovoltage X-Ray Therapy System; (4) Xstrahl 300 - 300kV Orthovoltage X-Ray Therapy System; (5) Xstrahl X 80 Photoelectric Therapy System.
Reason
If a saved treatment plan with 2 opposing beams is edited prior to approval, then Beam 2 is not updated with the changed parameters upon selecting save, resulting in error messages during the treatment and possible mis-treatment.
Identifiers
| code_info | V2.0, V2.1, and V2.2 when 2 opposing beam treatment plans are used. |
|---|
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-0174-2022%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.