Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
iGUIDE System Recalled by Elekta, Inc. Due to If by mistake the initial pre-treatment imaging was...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Elekta, Inc. directly.
Affected Products
iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment.
Quantity: 20
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 2 states: IL, LA
About Elekta, Inc.
Elekta, Inc. has 100 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report