Concerto User Interface Software provided with the following systems: — Class II medical device recall Z-0174-2022
Terminated recall by Xstrahl Limited, reported 2021-11-03, distributed nationwide. If a saved treatment plan with 2 opposing beams is edited prior to approval, then Beam 2 is not updated with t
| Recall number | Z-0174-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Xstrahl Limited, Walsall, N/A, United Kingdom |
| Recall initiated | 2021-04-26 |
| Classified | 2021-10-26 |
| Reported by FDA | 2021-11-03 |
| Terminated | 2024-01-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, CH, DE |
| Quantity | 25 systems |
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 for recall
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.
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-0174-2022. 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.