Apr

2012

Cl ll RayStation Version 2.0.0.15

Company:RAYSEARCH Laboratories AB,.
Date of Enforcement Report 4/11/12
Class ll:

PRODUCT
RayStation Version 2.0.0.15, Radiation Therapy Treatment Planning System. Model RayStation 2.0. Designed for treatment planning and analysis of radiation therapy. Recall # Z-1317-2012

REASON
An issue was found with the dose calculation, that could result in a potential overestimation of the dose. This could lead to the potential under-dosage of a patient.

RECALLING FIRM/MANUFACTURER
RAYSEARCH Laboratories AB, Stockholm, Sweden, by letters on December 6, 2011. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
21 devices (16 nationwide and 5 internationally)

DISTRIBUTION
Nationwide and the Netherlands

About the author

Amy Sellers

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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Cl ll RayStation Version 2.0.0.15

Amy Sellers

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