Company: ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System).
Date of Enforcement Report: 3/17/2021
Class II
PRODUCT
ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System).
Recall Number: Z-1185-2021
REASON
In case of a failed automatic marker detection, a software error causes parts of the display to incorrectly behave as if the current patient position is within predefined tolerances and may allow the user to proceed to treatment despite potentially exceeding shift values.
RECALLING FIRM/MANUFACTURER
ExacTrac Dynamic on 3/1/2021. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
73 ExacTrac Dynamic systems (versions 1.0.0, 1.0.1, 1.0.2) have been manufactured and distributed
DISTRIBUTION
U.S. Nationwide and International