4 results
·
18ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
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 Therapy System; (4) Xstrahl 300 - 300kV Orthovoltage X-Ray Therapy System; (5) Xstrahl X 80 Photoelectric Therapy System.
FDA Recall
Terminated
·Xstrahl Limited·Product code JAD·April 26, 2021
Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system
FDA Recall
Terminated
·Xstrahl Limited·Product code JAD·August 27, 2021
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 Therapy System; (4) Xstrahl 300 - 300kV Orthovoltage X-Ray Therapy System; (5) Xstrahl X 80 Photoelectric Therapy System.
FDA Enforcement
Class II
·Terminated·Xstrahl Limited·November 3, 2021
Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system
FDA Enforcement
Class II
·Terminated·Xstrahl Limited·December 22, 2021