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 Z-0174-2022 · Posted None
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Recalling FirmXstrahl Limited
Recall StatusTerminated
Product CodeJAD
Date Initiated2021-04-26
Date Terminated2024-01-26
Product Quantity25 systems in the U.S.
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.
Firm Action
The recalling firm issued an Urgent Field Safety Notice dated 4/26/2021 via email on 4/26/2021. The notice explained the issue, impact of the issue, and provided actions to be taken for Concerto 2.x 2 Beam Plans Only, although all customers with the affected software were issued the safety notice. The consignee was informed that until an update to their affected software version is installed, they should follow the actions listed in the letter.
Root Cause
Software design
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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