Company: Elekta Limited
Date of Enforcement Report: 6/17/2020
Class II

PRODUCT

Elekta Unity, Philips Marlin Software versions: R5.3.30, R5.3.31, R6.0.5331, R5.7.0, R5.7.1, R6.1.571

Recall Number: Z-2297-2020

REASON

In TSM (Treatment Session Manager) Motion Monitoring workflows, under certain conditions there can be a mismatch between the contour data overlay with respect to the motion monitoring images of the monitored structure.

RECALLING FIRM/MANUFACTURER

Elekta Limited on 5/21/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

26 units

DISTRIBUTION

U.S. Nationwide and International