Class II — MIM Software Inc
| Recalling firm | MIM Software Inc. |
|---|---|
| Registered facility | MIM SOFTWARE INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | MIM software; System, Image Processing, Radiological |
| Quantity | 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. |
| Initiated | 2025-02-19 |
| Classified | 2025-03-04 |
| Recall number | Z-1267-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — MIM Software Inc (Z-1267-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96314/
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