Cl II Radiation Therapy Treatment Planning System

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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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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