Class II

Medical Device Recall: MIM software; System, Image Processing, Radiological

MIM Software Inc · February 19, 2025

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.

States Affected

NATIONWIDE

Quantity Affected

352 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1267-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

MIM Software Inc Medical Device Recall: MIM software; System, Image Processing, Radiological | SafeCheck