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U.S. Department of Health and Human Services

Class 2 Device Recall Concerto

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 Class 2 Device Recall Concertosee related information
Date Initiated by FirmApril 26, 2021
Create DateOctober 26, 2021
Recall Status1 Terminated 3 on January 26, 2024
Recall NumberZ-0174-2022
Recall Event ID 88732
510(K)NumberK172080 K962613 
Product Classification System, therapeutic, x-ray - Product Code JAD
ProductConcerto 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.
Code Information V2.0, V2.1, and V2.2 when 2 opposing beam treatment plans are used.
Recalling Firm/
Manufacturer		 Xstrahl Limited
Unit 2
Maybrook Industrial Estate Maybro; Maybrook Road
Walsall United Kingdom
For Additional Information ContactMr. Sajid Rafiq
44(0)1543688920
Manufacturer 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.
FDA Determined
Cause 2		Software design
ActionThe 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 in Commerce25 systems in the U.S.
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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JAD
510(K)s with Product Code = JAD
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