MIM Software Inc: Device Recall
Recall #Z-1267-2025 · 02/19/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1267-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- MIM Software Inc
- Status
- Ongoing
- Date Initiated
- 02/19/2025
- Location
- Cleveland, OH, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 352 units
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.
Product Description
MIM software; System, Image Processing, Radiological
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.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.