Device 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.
Z-1846-2021
Product summary
- Firm
- Brainlab AG
- Event
- Event 87984
- Status
- Terminated
- Classification
- Class II
- Quantity
- 22 systems in the U.S.
- Official record key
device-enforcement:Z-1846-2021
Official wording
Reason: Display of potential patient movement might be delayed to the user for high dose treatments.
Code information: Version 1.02, GTIN 04056481142315
Distribution pattern: US Nationwide distribution in the states of AZ, AR, CA, FL, IN, NJ, NY, NC, OR, PA, and TX. There was no government/military distribution.
Derived failure modes
-
Unknown
Display of potential patient movement might be delayed to the user for high dose treatments.