Recall Z-0733-2022— Brainlab AG
Class II · Ongoing
Class II FDA medical device recall by Brainlab AG, initiated 2022-02-25. It names one FDA 510(k) clearance: K211939. Product: ExacTrac Dynamic software model numbers: 20910-01, 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.. Reason: The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs..
- Recalling firm
- Brainlab AG
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-02-25
- Firm location
- Munich, N/A, 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 software model numbers: 20910-01, 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.
Reason for recall
The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs.
Data sourced from openFDA. This site is unofficial and independent of the FDA.