20
Nov
2013

Ray Station Radiation Therapy Treatment ; Cl II

0

Company: RAYSEARCH LABORATORIES AB.
Date of Enforcement Report: 11/20/2013
Class lI:

PRODUCT

Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0
Recall Number Z-0281-2014

REASON
Ray Search Laboratories found an issue with the dose calculation for Elekta motorized wedges in Ray Station 3.0, 3.5 and 4.0. The error presents when a wedge is used for a beam and the wedge angle differs from 60 degrees.

RECALLING FIRM/MANUFACTURER
RAYSEARCH LABORATORIES AB, Stockholm, Sweden on 10/23/2013. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
195 units domestically

DISTRIBUTION
Nationwide

___________________________________

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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