FDA Medical Device Recalls (openFDA)
Xstrahl Limited: 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.
- Recall number
- Z-0174-2022
- 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.
- Status
- Terminated
- Initiated
- 2021-04-26
- Posted
- not on file
- Terminated
- 2024-01-26
- 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.
- 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
- 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.
- Lot, serial or model codes
- V2.0, V2.1, and V2.2 when 2 opposing beam treatment plans are used.
- 510(k) numbers
- K172080, K962613
- PMA numbers
- not on file
- Product code
- JAD
- Firm FEI
- 3004561814
- Firm city
- Walsall
- Firm state
- not on file
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28