Recall Z-1267-2025 ยท LLZ System, Image Processing, Radiological
MIM Software Inc
MIM software; System, Image Processing, Radiological
| Date | Mar 4, 2025 (initiated Feb 19, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Software design |
| Action | 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, progressio |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071964 | MIM 4.1 (SEASTAR) Mimvista Corp., Sep 26, 2007 |