Xstrahl recalls
Xstrahl appears in 3 official U.S. recall notices indexed by RecallRadar, most recently on 2022-07-27.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 3 |
|---|---|
| Published | 2021-11-03 to 2022-07-27 |
| By agency | FDA Device (3) |
| By classification | Class II (3) |
| By status | terminated (2), ongoing (1) |
| Distribution named in notices | CA, FL, KY, US |
Recalls
- X80 RADiant Photoelectric Therapy System
FDA Device · Class II · 2022-07-27 · Xstrahl
Reason: There is a potential compatibility issue with the systems and replacement treatment applicators. - Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system
FDA Device · Class II · 2021-12-22 · Xstrahl
Reason: Base plate may detach from the main body of the treatment applicator. - Concerto User Interface Software provided with the following systems: (1) Xstrahl 100 Electronic Brachytherapy - 100kV Superficial X-Ray Th…
FDA Device · Class II · 2021-11-03 · Xstrahl
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-…