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 1.0.0
    • 1.0.1
    • 1.0.2
    • 1.0.3
    • GTIN 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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:33 PM UTC

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