MIM (Software Package)
Brand(s)
Last updated
Summary
Product
MIM (Software Package)
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
---|---|---|
MIM (Software Package) |
N/A |
7.2 |
Issue
In situations where two images with differing fields of view (FOV) complete an image fusion, an incorrect, elevated maximum standardized uptake value (SUV) could result. This could lead to mistaken assessment of disease status, progression or response to treatment and potential inappropriate therapy.
Recall Start Date: February 21, 2025
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies
MIM Software Inc.
25800 Science Park Drive, Cleveland, Ohio, United States, 44122
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-77076
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