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

Recall Z-0281-2014 — Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0

U.S. FDA — Device Enforcement · Sweden · 2013-10-23 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0281-2014
Date of alert
2013-10-23
Country / jurisdiction
Sweden
Risk level
Class II
Risk type
recall
Brand
RAYSEARCH LABORATORIES AB
Product category
device
Product type
Devices
Reported risk: Ray Search Laboratories found an issue with the dose calculation for Elekta motorized wedges in Ray Station 3.0, 3.5 and 4.0. The error presents when a wedge is used for a beam and the wedge angle differs from 60 degrees.
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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