Recall Z-1846-2021— Brainlab AG
Class II · Terminated
Class II FDA medical device recall by Brainlab AG, initiated 2021-05-14, terminated 2023-03-20. It names one FDA 510(k) clearance: K203173. Product: ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 - Product Usage: intended to position patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, to monitor the patient position, and to provide a beam hold signal in case of a deviations in order to treat lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.. Reason: Display of potential patient movement might be delayed to the user for high dose treatments..
- Recalling firm
- Brainlab AG
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-05-14
- Terminated
- 2023-03-20
- 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 20910-01B ETD Positioning and Monitoring Installer 1.0.2 - Product Usage: intended to position patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, to monitor the patient position, and to provide a beam hold signal in case of a deviations in order to treat lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
Reason for recall
Display of potential patient movement might be delayed to the user for high dose treatments.
Data sourced from openFDA. This site is unofficial and independent of the FDA.