Recall Z-0174-2022 ยท JAD System, Therapeutic, X-Ray
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
| Date | Apr 26, 2021 |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |