MIM software; System, Image Processing, Radiological

FDA device recall Z-1267-2025 · posted 2025-03-04 · Open, Classified

Recall details

Recalling firm

MIM Software Inc

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.

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."

Root cause

Software design

Status

Open, Classified

Product code

LLZ

Quantity affected

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, Mexi

Date initiated

2025-02-19

Date posted

2025-03-04

Location

Cleveland, OH

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