FDA recall Z-1267-2025

MIM Software Inc · Class II · device

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

Status: Ongoing
Initiation date: 2025-02-19
Report date: 2025-03-12
Voluntary/Mandated: Voluntary: Firm initiated
Location: Cleveland, OH, United States

Primary source

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