The Recall Desk
ModerateFDA (Devices)·Z-2082-2019·Announced 2019-07-31

Medical Intelligence Recalls iGuide System Software Due to False Verification Alerts

Medical Intelligence Medizintechnik GmbH is recalling iGuide System software versions 2.2.0, 2.2.1, and 2.2.2 because the Constant Correlation Check may incorrectly demand verification scans.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a software sensitivity issue causing false verification demands rather than a direct physical injury or high-risk pathogen, fitting the criteria for moderate severity.

Plain-English summary

Medical Intelligence Medizintechnik GmbH is recalling iGuide System software versions 2.2.0, 2.2.1, and 2.2.2. The software is used in a radiotherapy environment to control accurate patient positioning with the assistance of a 30 Tracking System on linear accelerators.

The recall was issued because the Constant Correlation Check (CCC) can be too sensitive. In some instances, although the HexaPOD has reached the target position, the system may incorrectly demand a verification scan. This issue affects 496 units distributed worldwide and across the United States.

The source text does not specify consumer actions or report any injuries or illnesses associated with this software defect.

The recalled product

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.
Manufacturer
Medical Intelligence Medizintechnik Gmbh
Category
Medical Device — Radiotherapy Software
Hazard
Affected units
496

Distribution

Distributed nationwide across the United States.

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