FDAClass IISeptember 23, 2015

Radiation Therapy Treatment Planning System software recall

Radiation Therapy Treatment Planning System software RayStation is a software system designed for treatment planning and analysis of radiation…

Why was Radiation Therapy Treatment Planning System software recalled?

An error caused by a floating point precision problem tends to cause a problem with the display of isodose lines for dose and dose difference and color tables for dose, dose difference and PET images

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

software build numbers are 4.7.0.15 or 4.7.1.10

Product
Radiation Therapy Treatment Planning System software RayStation is a software system designed for treatment planning and analysis of radiation…
Recalling firm
RAYSEARCH LABORATORIES AB
Quantity
20 devices
Distribution
Worldwide Distribution: US (nationwide) to state of WA; and countries of: France, Sweden, Austria, Spain, Germany, Italy, UK, New Zealand.
Recall date
September 23, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls