Recall Z-1707-2014— Brainlab AG
Class II · Terminated
Class II FDA medical device recall by Brainlab AG, initiated 2014-04-15, terminated 2017-04-24. It names one FDA 510(k) clearance: K072506. Product: ExacTrac 5.5, an Image Processing System used for patient positioning for radiation therapy or radiosurgery.. Reason: When using a specific plan update workflow in combination with a non-Brainlab treatment planning system (TPS), there is a possibility in ExacTrac 5.5.5 to generate an unintended blend of two initially separate plans of the same patient..
- Recalling firm
- Brainlab AG
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-04-15
- Terminated
- 2017-04-24
- Firm location
- Feldkirchen, 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 5.5, an Image Processing System used for patient positioning for radiation therapy or radiosurgery.
Reason for recall
When using a specific plan update workflow in combination with a non-Brainlab treatment planning system (TPS), there is a possibility in ExacTrac 5.5.5 to generate an unintended blend of two initially separate plans of the same patient.
Data sourced from openFDA. This site is unofficial and independent of the FDA.