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

Recall Z-1427-2021 — RayStation Model Number: (9A)9.0.0.113, 9B (9.1.0.933), 9B Service pack (9.2.0.483), 10A (10.0.0.1154), 10A Service pack (10.0.1.52), 10B (10.1.0.613)

U.S. FDA — Device Enforcement · Sweden · 2021-03-25 · Class II

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1427-2021
Date of alert
2021-03-25
Country / jurisdiction
Sweden
Risk level
Class II
Risk type
recall
Brand
RAYSEARCH LABORATORIES AB
Product category
device
Product type
Devices
Reported risk: Flags edited in RayCare after a patient has been checked in may not always be updated in RayTreat.
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.

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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.