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

Recall Z-0736-2020 — RayStation stand-alone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0 - Product Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-

U.S. FDA — Device Enforcement · Sweden · 2019-11-18 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0736-2020
Date of alert: 2019-11-18
Country / jurisdiction: Sweden
Risk level: Class II
Risk type: recall
Brand: RAYSEARCH LABORATORIES AB
Product category: device
Product type: Devices

Reported risk: Editing a static arc beam may unexpectedly set the MU of the beam to its initial default value of 200 MU. If the bug is triggered, the dose is invalidated and needs to be recalculated before the plan can be approved or exported.

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

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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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