Recall Z-1185-2021— Brainlab AG
Class II · Terminated
Class II FDA medical device recall by Brainlab AG, initiated 2021-03-01, terminated 2023-03-20. It names one FDA 510(k) clearance: K201276. Product: ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System).. Reason: 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..
- Recalling firm
- Brainlab AG
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-03-01
- Terminated
- 2023-03-20
- Firm location
- Munich, Germany
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System).
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.