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

Recall Z-1464-2020 — RayStation/RayPlan 8B, Build Number 8.1.0.47, stand-alone software treatment planning system

U.S. FDA — Device Enforcement · Sweden · 2020-02-20 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1464-2020
Date of alert
2020-02-20
Country / jurisdiction
Sweden
Risk level
Class II
Risk type
recall
Brand
RAYSEARCH LABORATORIES AB
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
07350002010129
Reported risk: There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, non-zero pitch or roll causes the lateral, longitudinal and vertical values propagated to be incorrect.
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.