Xstrahl Limited Recall 88732
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.
Xstrahl Limited Recall 88732 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-0174-2022 |
Event ID | 88732 |
Event 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. |
Product Type | Devices |
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. |
Quantity | 25 systems in the U.S. |
Recall 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. |
Device Classification | 20211103 |
Device Code Info | V2.0, V2.1, and V2.2 when 2 opposing beam treatment plans are used. |
Center Classification Date | 20211026 |
Recall Initiation Date | 20210426 |
Recalling Firm | Xstrahl Limited |
Initial Notification | Letter |
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