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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- Affected units
- 496
Distribution
Distributed nationwide across the United States.
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