Reported Nov 3, 2021 · Terminated
Concerto User Interface Software provided with the following systems
Xstrahl Limited
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Xstrahl Limited · Unit 2 · Walsall, N/A · N/A
Is this the product you have?
Concerto User Interface Software provided with the following systems
5 of 5 products
| # | Product as published |
|---|---|
| 1 | (1) Xstrahl 100 Electronic Brachytherapy - 100kV Superficial X-Ray Therapy System |
| 2 | (2) Xstrahl 150 Electronic Brachytherapy - 150kV Superficial X-Ray Therapy System |
| 3 | (3) Xstrahl 200 - 225kV Superficial / Orthovoltage X-Ray Therapy System |
| 4 | (4) Xstrahl 300 - 300kV Orthovoltage X-Ray Therapy System |
| 5 | (5) Xstrahl X 80 Photoelectric Therapy System. |
- Lot codes and dates
- V2.0, V2.1, and V2.2 when 2 opposing beam treatment plans are used.
- Amount recalled
- 25 systems in the U.S.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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