Quick summary
Quick summary: MIM (Software Package). Date: 2025-03-07.
Public recall detail
MIM (Software Package)
2025-03-07
Recall
Safety notice
Recommended action
Recommended action: compare your product with the official notice and follow the instructions published by the official source.
Recall details
Quick summary: MIM (Software Package). Date: 2025-03-07.
Official details
Affected product details
Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.
BrandMIM Software Inc.
ProductMIM (Software Package)
IssueMedical devices - Performance
Recall classType II
IdentificationRA-77076
Affected products
ProductMIM (Software Package)
LotN/A
Model7.2
Serial numberN/A
DescriptionMIM (Software Package)
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
What you should do
- Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Radiology
CompaniesMIM Software Inc. 25800 Science Park Drive, Cleveland, Ohio, United States, 44122
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-77076
Background{}
CompaniesMIM Software Inc. 25800 Science Park Drive, Cleveland, Ohio, United States, 44122
AudiencesHealthcare
Source updated2025-03-07
Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.
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