Company: MIM Software Inc
Date of Enforcement Report: 3/04/2025
Class II
PRODUCT
MIM software; System, Image Processing, Radiological
Recall Number:
Z-1252-2025
REASON:
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.
RECALLING FIRM/MANUFACTURER:
MIM Software Inc
VOLUME OF PRODUCT IN COMMERCE:
352 units
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
