Reported Mar 17, 2021 · Terminated
ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System).
Brainlab AG
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: Brainlab AG · Olof-palme-str. 9 · Munich · N/A
Is this the product you have?
- ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System).
- Lot codes and dates
- Model/catalogue numbers20910-06 ETD Implanted lic
- UDIThe GTIN for ExacTrac Dynamic version 1.0 is 04056481142315
- GMDN code40887. Software revisions
- of affected ExacTrac Dynamic software
versions 1.0.01.0.11.0.2
- Amount recalled
- 73 ExacTrac Dynamic systems (versions 1.0.0, 1.0.1, 1.0.2) have been manufactured and distributed
Where it was sold
Why it was recalled
In case of a failed automatic marker detection, a software error causes parts of the display to incorrectly behave as if the current patient position is within predefined tolerances and may allow the user to proceed to treatment despite potentially exceeding shift values.
This product could cause temporary or reversible health problems — stop using it.
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