# FDA recall Z-0174-2022

> **Xstrahl  Limited** · Class II · device recall initiated 2021-04-26.

## 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.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of AZ, CA, FL, KY, NV, OR, PA, TN, and TX.  The countries of Austria, Germany, and Switzerland.

## Key facts

- **Recall number:** Z-0174-2022
- **Recalling firm:** Xstrahl  Limited
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-04-26
- **Report date:** 2021-11-03
- **Termination date:** 2024-01-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Walsall, N/A, United Kingdom

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0174-2022

## Citation

> AI Analytics. FDA recall Z-0174-2022. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/Z-0174-2022. Source: US FDA. Licensed CC0.

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