Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1815-2017 — Radiation Therapy Treatment Planning System, Model 4.5, 4.7, 5.0 RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment

U.S. FDA — Device Enforcement · Sweden · 2017-01-18 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1815-2017
Date of alert: 2017-01-18
Country / jurisdiction: Sweden
Risk level: Class II
Risk type: recall
Brand: RAYSEARCH LABORATORIES AB
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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