# FDA recall Z-1267-2025

> **MIM Software Inc** · Class II · device recall initiated 2025-02-19.

## Product

MIM software; System, Image Processing, Radiological

## Reason for recall

In situations where two images with differing Fields of View (FOV) complete an image fusion, an incorrect, elevated Maximum Standardized Uptake Value (SUV)   within MIM Software versions 7.2.0 through  7.2.6.could result.

## Distribution

Worldwide distribution - United States Nationwide and the countries of Australia, Belgium, Bolivia, Canada, China, Croatia, Czech Republic, Denmark, France, Germany, Greece, Israel, Italy, Japan, Mexico, Netherlands, Poland, Russia, Spain, Sweden, United Kingdom, Finland, Hong Kong.

## Key facts

- **Recall number:** Z-1267-2025
- **Recalling firm:** MIM Software Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-02-19
- **Report date:** 2025-03-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cleveland, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1267-2025

## Citation

> AI Analytics. FDA recall Z-1267-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1267-2025. Source: US FDA. Licensed CC0.

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