MIM Software Inc recalls MIM software; System, Image Processing, Radiological

Recall date

February 19, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1267-2025

FDA classification

Class II

Brand / firm

MIM Software Inc

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

MIM software; System, Image Processing, Radiological