FDA Device recall Z-1267-2025
MIM software
- FDA Device
- Class II
- ongoing
- Published 2025-03-12
On 2025-03-12 the FDA classified a Class II recall of MIM software by Mim Software, citing 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 ver….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1267-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-02-19 |
| Published | 2025-03-12 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Mim Software |
| Distribution | US |
Product
MIM software; System, Image Processing, Radiological
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.
Identifiers
| code_info | 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/…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1267-2025%22
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