# FDA recall Z-2082-2019

> **Medical Intelligence Medizintechnik Gmbh** · Class II · device recall initiated 2019-07-18.

## Product

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.

## Reason for recall

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.

## Distribution

Worldwide Distribution - US Nationwide

## Key facts

- **Recall number:** Z-2082-2019
- **Recalling firm:** Medical Intelligence Medizintechnik Gmbh
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-07-18
- **Report date:** 2019-07-31
- **Termination date:** 2023-08-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Schwabmunchen, N/A, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2082-2019

## Citation

> AI Analytics. FDA recall Z-2082-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2082-2019. Source: US FDA. Licensed CC0.

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