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Recall Observatory FDA recall evidence

Device product

MIM software; System, Image Processing, Radiological

Z-1267-2025

February 19, 2025

Class II

Product summary

Firm
MIM Software Inc
Event
Event 96314
Status
Ongoing
Classification
Class II
Quantity
352 units
Official record key
device-enforcement:Z-1267-2025

Official wording

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.

Code information: Software versions: 1. MIM Anyware 1.1, UDI/DI Not Applicable 2. MIM 7.2.0, UDI/DI 00850009343192; 3. MIM 7.2.1, UDI/DI 00850009343192; 4. MIM 7.2.2, UDI/DI 00850009343192; 5. MIM 7.2.3, UDI/DI 00850009343192; 6. MIM 7.2.4, UDI/DI 00850009343192; 7. MIM 7.2.5, UDI/DI 00850009343192; 8. MIM 7.2.6, UDI/DI 00850009343192

Distribution pattern: 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.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    Software versions 7.2.0 through 7.2.6.could