Z-0174-2022 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 3, 2021
- Initiation Date
- April 26, 2021
- Termination Date
- January 26, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 25 systems in the U.S.
Product Description
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.
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.
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.
Code Information
V2.0, V2.1, and V2.2 when 2 opposing beam treatment plans are used.