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