FDA-Device2020-06-17Class II
Elekta Unity, Philips Marlin Software versions: R5.3.30, R5.3.31, R6.0.5331, R5.7.0, R5.7.1, R6.1.571
Elekta Limited
Hazard
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.
Sold states
US distribution to IA, NY, PA, TX, WI. International distribution to Australia, Canada, China, Denmark, Germany, Hong Kong, Italy, Netherlands, Sweden, Switzerland, Turkey, United Kingdom.
Affected count
26 units
Manufactured in
Linac House, Fleming Way, Crawley, N/A, United Kingdom
Products
Elekta Unity, Philips Marlin Software versions: R5.3.30, R5.3.31, R6.0.5331, R5.7.0, R5.7.1, R6.1.571
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2297-2020Don't want to check this manually?
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