Recall Z-1267-2025
MIM Software Inc · initiated February 19, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
MIM software; System, Image Processing, Radiological
Codes / lots: 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
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.
FDA-determined cause: Software design
Action taken
GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 02/19/2025 disseminated using a traceable means. The notice explained the issue, potential risk to the patient, and provided the following actions to be taken to use the device: "You can continue to use your device if you are not using the SUV tool or if you access a non-impacted version of MIM when using the SUV tool. If using a non-default workflow and fusing a PET or SPECT image with another image with a different FOV, do not incorporate the Maximum SUV value into assessment of disease status, progression or response to treatment. NOTE: MIM s default workflows do not fuse images with differing FOV, and the Maximum SUV values reported are correct. If you are using the SUV tool and are unsure if you are affected by this issue, please contact your MIM Site Development Manager, your Distributor for MIM Software, or MIM Customer Support." "Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions."
Details
- Recall number
- Z-1267-2025
- Initiated
- February 19, 2025
- Posted by FDA
- March 4, 2025
- Product code
- LLZ – 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.
- Recalling firm
- MIM Software Inc, Cleveland, OH