Z-0174-2022Class II

Concerto User Interface Software provided with the following systems: (1) Xstrahl 100 Electronic...

Name: Z-0174-2022 Concerto User Interface Software provided with the following systems: (1) Xstrahl 100 Electronic...
Creator: Xstrahl Limited
Published: 2021-04-26
License: https://open.fda.gov/license/

Xstrahl Limited / initiated 2021-04-26 / Terminated / root cause: software

FDA source

Xstrahl Limited began a recall of Concerto User Interface Software provided with the following systems: (1) Xstrahl 100 Electronic Brachytherapy - 100kV Superficial X-Ray Therapy System; (2)... on 2021-04-26. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0174-2022
Classification: Class II
Status: Terminated
Initiated: 2021-04-26
Posted: 2021-10-26
Terminated: 2024-01-26
Recalling firm: Xstrahl Limited
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.
Product code: JAD System, Therapeutic, X-Ray
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.
Root cause tag: software
FDA root cause: Software design
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.
Quantity in commerce: 25 systems in the U.S.
Distribution: 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.
Product codes and lots: V2.0, V2.1, and V2.2 when 2 opposing beam treatment plans are used.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0174-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0174-2022	Class II	Terminated	Voluntary: Firm initiated	2021-11-03	2021-10-26

Product code JAD

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)