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

Recall Z-0721-2017 — RayStation 4.0, 4.5, 4.7 and 5.0; Radiation Therapy Treatment Planning System Product Usage: 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 expecte

U.S. FDA — Device Enforcement · Sweden · 2016-11-09 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0721-2017
Date of alert: 2016-11-09
Country / jurisdiction: Sweden
Risk level: Class II
Risk type: recall
Brand: RAYSEARCH LABORATORIES AB
Product category: device
Product type: Devices

Reported risk: Software anomaly; an issue was found with the proton Pencil Beam Scanning (PBS) dose calculation in RayStation 4.0, 4.5, 4.7 and 5.0. For treatment plans with a combination of range shifter, large air gap and beams that enter the patient surface at an oblique angle, the dose calculation accuracy may be less than expected.

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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