FDAFebruary 19, 2025device

MIM software; System, Image Processing, Radiological

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

mim softwaremim

UPCs

00850009343192

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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