Xstrahl Limited FDA Recalls

3 recalls on file across devices, 0 of them Class I and 1 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
X80 RADiant Photoelectric Therapy SystemClass IIApr 27, 2022There is a potential compatibility issue with the systems an	There is a potential compatibility issue with the systems and replacement treatment applicators.	Class IIDevices	Apr 27, 2022
Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy systemClass IIAug 27, 2021Base plate may detach from the main body of the treatment ap	Base plate may detach from the main body of the treatment applicator.	Class IIDevices	Aug 27, 2021
Concerto User Interface Software provided with the following systems: (1) Xstrahl 100 Electronic Brachytherapy - 100kClass IIApr 26, 2021If a saved treatment plan with 2 opposing beams is edited pr	If a saved treatment plan with 2 opposing beams is edited prior to approval, then Beam 2 is not updated with t	Class IIDevices	Apr 26, 2021