Brainlab AG Olof-palme-str. 9 Munich Germany 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Brainlab AG Olof-palme-str. 9 Munich Germany
Lot Codes / Batch Numbers
Version 1.02, GTIN 04056481142315
Products Sold
Version 1.02, GTIN 04056481142315
Brainlab AG Olof-palme-str. 9 Munich Germany is recalling ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 - Product due to Display of potential patient movement might be delayed to the user for high dose treatments.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Display of potential patient movement might be delayed to the user for high dose treatments.
Recommended Action
Per FDA guidance
An Urgent Field Safety Notice/Product Notification dated 4/29/2021 was issued on 5/14/2021 via email explaining the safety issue and letting the customer know that this issue is in addition to the previous notification of 9/8/2020 which has now expanded to versions 1.0.1 and 1.0.2.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026