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