Xstrahl recalls

3 official recalls and safety alerts involving Xstrahl since 2021-11, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Xstrahl or the relevant agency.

  1. 2022-07-27
  2. US
    Drugs & medicalClass II

    Xstrahl Limited recalls X80 RADiant Photoelectric Therapy System

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

    FDA · DeviceXstrahl LimitedUS Distribution FL, CA, KYOfficial notice →
  3. 2021-12-22
  4. US
    Drugs & medicalClass II

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

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

    FDA · DeviceXstrahl LimitedUS and ALGERIA, AUSTRALIA, AUSTRIA, BULGARIA, CANADA, COSTA RICA, CROATIA,…Official notice →
  5. 2021-11-03
  6. US
    Drugs & medicalClass II

    Xstrahl Limited recalls Concerto User Interface Software provided with the following systems: (1) Xstrahl 100 Electronic Brachytherapy - 100kV Superficial X-Ray…

    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…

    FDA · DeviceXstrahl LimitedWorldwide distribution - US Nationwide distribution in the states of AZ, CA,…Official notice →