MIM software — Class II medical device recall Z-1267-2025
Ongoing recall by MIM Software Inc, reported 2025-03-12, distributed nationwide. In situations where two images with differing Fields of View (FOV) complete an image fusion, an incorrect, ele
| Recall number | Z-1267-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MIM Software Inc, Cleveland, OH, United States |
| Recall initiated | 2025-02-19 |
| Classified | 2025-03-04 |
| Reported by FDA | 2025-03-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, BO, CA, CN, CZ, DE, DK, ES, FI, FR, GB, GR, HK, HR, IL, IT, JP, MX, NL, PL, RU, SE |
| Quantity | 352 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00850009343192 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1267-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.