Reported Mar 12, 2025 · Ongoing

MIM software; System, Image Processing, Radiological

MIM Software Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: MIM Software Inc · 25800 Science Park Dr Ste 180 · Cleveland, OH · 44122-7311

Is this the product you have?

  • MIM software; System, Image Processing, Radiological
Lot codes and dates

8 of 8 products

Products covered by this recall
#BarcodesProduct as published
1MIM Anyware 1.1, UDI/DI Not Applicable
200850009343192MIM 7.2.0, UDI/DI 00850009343192
300850009343192MIM 7.2.1, UDI/DI 00850009343192
400850009343192MIM 7.2.2, UDI/DI 00850009343192
500850009343192MIM 7.2.3, UDI/DI 00850009343192
600850009343192MIM 7.2.4, UDI/DI 00850009343192
700850009343192MIM 7.2.5, UDI/DI 00850009343192
800850009343192MIM 7.2.6, UDI/DI 00850009343192
Amount recalled
352 units

Where it was sold

  • Nationwide

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:38 PM UTC

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