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
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