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

Recall Z-1275-2018 — Ray Station 4.9 Ray Station 5, Ray Station 6 and Ray Station 7 Software build numbers: 4.9.0.42, 5.0.0.37, 5.0.1.11, 5.0.2.35, 6.0.0.24, 6.1.0.26, 6.1.1.2, 6.2.0.7 or 7.0.0.19 UDI: 0735000201006820171130

U.S. FDA — Device Enforcement · Sweden · 2018-01-26 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1275-2018
Date of alert
2018-01-26
Country / jurisdiction
Sweden
Risk level
Class II
Risk type
recall
Brand
RAYSEARCH LABORATORIES AB
Product category
device
Product type
Devices
Reported risk: Software issue with Center Beam in Field functionality. Issue can result in incorrect treatment volume delivered to patient.
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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