Xstrahl Limited Recalls

X80 RADiant Photoelectric Therapy System

Class I - Dangerous

There is a potential compatibility issue with the systems and replacement treatment applicators.

Apr 27, 2022 Other Medical Devices View Details →

Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system

Class I - Dangerous

Base plate may detach from the main body of the treatment applicator.

Aug 27, 2021 Other Medical Devices View Details →

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.

Class I - Dangerous

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.

Apr 26, 2021 Other Medical Devices Nationwide View Details →