Product Safety Recalls

Product Recall Tracker

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

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0174-2022
Event ID88732
Event DescriptionConcerto 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 TypeDevices
DistributionWorldwide 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.
Quantity25 systems in the U.S.
Recall ReasonIf 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 Classification20211103
Device Code InfoV2.0, V2.1, and V2.2 when 2 opposing beam treatment plans are used.
Center Classification Date20211026
Recall Initiation Date20210426
Recalling FirmXstrahl Limited
Initial Notification Letter
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