Recall Z-1259-2023— Brainlab AG
Class II · Ongoing
Class II FDA medical device recall by Brainlab AG, initiated 2023-02-14. It names one FDA 510(k) clearance: K220338. Product: Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F.. Reason: Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a standard-workflow Treatment Template.
- Recalling firm
- Brainlab AG
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-02-14
- 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
Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F.
Reason for recall
Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a standard-workflow Treatment Template
Data sourced from openFDA. This site is unofficial and independent of the FDA.