FDA-Device2021-11-03Class II
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.
Xstrahl Limited
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.
Sold states
Worldwide distribution - US Nationwide distribution in the states of AZ, CA, FL, KY, NV, OR, PA, TN, and TX. The countries of Austria, Germany, and Switzerland.
Affected count
25 systems in the U.S.
Manufactured in
Unit 2, Maybrook Industrial Estate Maybro; Maybrook Road, Walsall, N/A, United Kingdom
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0174-2022Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief