Skip to content
Recall Observatory FDA recall evidence

Device product

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.

Z-0174-2022

April 26, 2021

Class II

Product summary

Firm
Xstrahl Limited
Event
Event 88732
Status
Terminated
Classification
Class II
Quantity
25 systems in the U.S.
Official record key
device-enforcement:Z-0174-2022

Official wording

Reason: 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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.