Summary
The FDA issued a Class II for MIM software; System, Image Processing, Radiological by MIM Software Inc. Reason: In situations where two images with differing Fields of View (FOV) complete an image fusion, an incorrect, elevated Maximum Standardized Uptake Value .
Details
Source
Device Recall
External ID
Z-1267-2025
Action Date
2025-03-12
Status
Ongoing
Category
device
Product Description
MIM software; System, Image Processing, Radiological
Lot/Code Info: 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
Quantity Affected: 352 units
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-02-19
Company
Cleveland, OH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 132 device recalls issued in the same week, part of 403 device-related FDA actions this month.
MIM Software Inc has 13 FDA actions in our database, including 1 recall and 12 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (MIM Software Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does MIM Software Inc have FDA actions?
MIM Software Inc has 13 FDA actions in our database, including 1 recall and 12 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1267-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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