FDAClass IIApril 19, 2017

Radiation Therapy Treatment Planning System recall: Software Issue

Radiation Therapy Treatment Planning System, Model 4.5, 4.7, 5.0 RayStation is a software system designed for treatment planning and analysis of…

Why was Radiation Therapy Treatment Planning System recalled?

An error in NVIDIA GPU (Graphics Processing Unit) card drivers can occur for certain software programs. In a non-standard Citrix environment where the GPU settings are configured with a virtual Citrix graphics board (graphics card) an erroneous calculation may be allowed.

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?

4.5.0.19, 4.5.1.14, 4.5.2.7, 4.7.0.15, 4.7.1.10, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4, 5.0.0.37, 5.0.1.11, 5.0.2.35

Product
Radiation Therapy Treatment Planning System, Model 4.5, 4.7, 5.0 RayStation is a software system designed for treatment planning and analysis of…
Recalling firm
RAYSEARCH LABORATORIES AB
Quantity
741 units
Distribution
Nationwide Distribution to AR, AZ, CA, CO, CT, DE, FL, GA, HI, IL, LA, MN, MD, MA, MI, MS, MT, NJ, NY, NC, NV, OH, OK, OR, PA, RI, TN, TX, VA, VT, VI, WA, WI, and Washington D.C.
Recall date
April 19, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
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