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

Recall Z-1705-2016 — iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment.

U.S. FDA — Device Enforcement · United States · 2016-05-12 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1705-2016
Date of alert
2016-05-12
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Elekta, Inc.
Product category
device
Product type
Devices
Reported risk: If by mistake the initial pre-treatment imaging was performed BEFORE the HexaPOD was moved to the DRIVE (*START) position, iGUIDE offers the possibility to branch into a specific catch-up workflow, which was implemented to use the initial scan data.
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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