Class II — Potential Health Hazard

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...

Date: July 18, 2019
Company: Medical Intelligence Medizintechnik Gmbh
Status: Terminated
Source: FDA (Device)

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.

Affected (51 states)Not affected

About Medical Intelligence Medizintechnik Gmbh

Medical Intelligence Medizintechnik Gmbh has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report