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

Recall Z-0294-2019 — RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7, a stand-alone software treatment planning system.

U.S. FDA — Device Enforcement · Sweden · 2018-09-21 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0294-2019
Date of alert
2018-09-21
Country / jurisdiction
Sweden
Risk level
Class II
Risk type
recall
Brand
RAYSEARCH LABORATORIES AB
Product category
device
Product type
Devices
Reported risk: Robust optimization for plans using beam set + background dose is not supported in RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7.
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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