FDAApril 26, 2021device
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 Ther...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
xstrahl
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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