Walsall, N/A, United Kingdom
Xstrahl Limited recalls
3 recalls recorded since 2018, most recently on 27 April 2022. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)1
Terminated or completed2
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 27 April 2022
- Reason
- There is a potential compatibility issue with the systems and replacement treatment applicators.
- Distribution
- US Distribution FL, CA, KY
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1404-2022
- X80 RADiant Photoelectric Therapy System
Terminated Class II Medical devices
- Recall started
- 27 August 2021
- Terminated
- 4 March 2026
- Reason
- Base plate may detach from the main body of the treatment applicator.
- Distribution
- US and ALGERIA, AUSTRALIA, AUSTRIA, BULGARIA, CANADA, COSTA RICA, CROATIA, CYPRUS, DENMARK, FRANCE, GERMANY, HONG KONG, IRELAND, ITALY, KAZAKHSTAN, LATVIA, MALTA, MEXICO, NEW ZEALAND, NORWAY, PANAMA, ROMANIA, RUSSIA, SAUDI ARABIA, SPAIN, SWEDEN, SWITZERLAND, UK, UKRAINE
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0389-2022
- Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system
Terminated Class II Medical devices
- Recall started
- 26 April 2021
- Terminated
- 26 January 2024
- 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.
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0174-2022
- 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-
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.