Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
IGuide System Recalled by Medical Intelligence Medizintechnik Gmbh Due to Sometimes, although the HexaPOD has reached the target...
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 Medical Intelligence Medizintechnik Gmbh directly.
Affected Products
IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator. The intended use of the device is the control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.
Quantity: 496 units
Why Was This Recalled?
Sometimes, although the HexaPOD has reached the target position, the Constant Correlation Check (CCC) can be too sensitive and iGUIDE may incorrectly demand a verification scan.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Medical Intelligence Medizintechnik Gmbh
Medical Intelligence Medizintechnik Gmbh has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report