Company: RAYSEARCH LABORATORIES AB
Date of Enforcement Report 10/12/2016
Class lI:
PRODUCT
Radiation Therapy Treatment Planning System, Model 5.0
Recall Number Z-0079-2017
REASON
For a treatment plan consisting of multiple beam sets, the table for ROI plan dose statistics in the report may show the statistics for a beam set dose. The error can only be triggered when using a report template where statistics for a beam set dose is included as the last dose statistics prior to the plan dose statistics. less…
RECALLING FIRM/MANUFACTURER
RAYSEARCH LABORATORIES AB, Stockholm, Sweden on 10/13/2016 Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
491 units
DISTRIBUTION
AZ, CA, FL, MT, NC NY, TX, OH & WA
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