Concerto User Interface Software provided with the following systems: (1) Xstrahl 100 Electronic Brachytherapy - 100k
Summary
The FDA issued a Class II for Concerto User Interface Software provided with the following systems: (1) Xst by Xstrahl Limited. 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 sav.
Details
Source
Device Recall
External ID
Z-0174-2022
Action Date
2021-11-03
Status
Terminated
Category
device
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.
Lot/Code Info: V2.0, V2.1, and V2.2 when 2 opposing beam treatment plans are used.
Quantity Affected: 25 systems in the U.S.
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
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-04-26
Company
Walsall, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 124 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Xstrahl Limited has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Xstrahl Limited) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Xstrahl Limited have FDA actions?
Xstrahl Limited has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0174-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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