FDAApril 27, 2022device
X80 RADiant Photoelectric Therapy System
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
There is a potential compatibility issue with the systems and replacement treatment applicators.
What to do
FDA enforcement status: Ongoing
Brands named
xstrahl
UPCs
5060494200008
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDATreatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system2021-08-27
- FDAConcerto 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 Ther...2021-04-26
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