Xstrahl Limited: Medical Device Recall in 2021 - (Recall #: Z-0174-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: April 26, 2021

Date Posted: November 3, 2021

Recall Number: Z-0174-2022

Event ID: 88732

Reason for Recall:

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.

Status: Terminated

Product Quantity: 25 systems in the U.S.

Code Information:

V2.0, V2.1, and V2.2 when 2 opposing beam treatment plans are used.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated