Reported Mar 16, 2022 · Ongoing
ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INST; 20910-01A, ETD Positioning and…
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 · N/A
Is this the product you have?
- ExacTrac Dynamic software model numbers20910-01, ETD Positioning and Moni. 1.0.0 INST; 20910-01A, ETD Positioning and Moni. 1.0.1 INST; 20910-01B, ETD Positioning and Moni. 1.0.2 INST; and 20910-01C ETD Positioning and Moni. 1.0.3 INST
- Lot codes and dates
Software versions 1.0.01.0.11.0.21.0.3GTIN 04056481142315
- Amount recalled
- 205 systems
Where it was sold
Why it was recalled
The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs.
This product could cause temporary or reversible health problems — stop using it.
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