RAYSEARCH LABORATORIES AB recalls Radiation Therapy Treatment Planning System, Model 5.0

Recall date

May 30, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0079-2017

FDA classification

Class II

Brand / firm

RAYSEARCH LABORATORIES AB

Sold / distributed

AZ, CA, FL, MT, NC NY, TX, OH & WA

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Radiation Therapy Treatment Planning System, Model 5.0