MIM Radiological Imaging Software Versions May Generate Incorrect Diagnostic Values
MIM radiological software versions 7.2.0-7.2.6 may produce incorrect readings when fusing images with different fields of view, which could affect diagnostic accuracy.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall with no reported hospitalizations or injuries. The recall addresses a risk-of-harm product (radiological diagnostic software) where incorrect readings could affect diagnostic accuracy. Per the severity rubric, risk-of-harm products without reported injury are scored at 3 (High).
Plain-English summary
MIM Software Inc is recalling specific versions of its MIM software, a radiological image processing system used in healthcare facilities. The recall affects 352 units running MIM versions 7.2.0 through 7.2.6 and MIM Anyware 1.1.
When the software combines two radiological images with different fields of view, it can calculate incorrect, elevated Maximum Standardized Uptake Value (SUV) readings. SUV is a key measurement used in medical image analysis. Incorrect readings could affect the accuracy of diagnostic interpretation.
The affected software has been distributed worldwide, including throughout the United States and in multiple countries including Canada, the United Kingdom, Australia, Germany, Japan, France, Italy, and others. Healthcare organizations using affected versions should verify their current software version and contact MIM Software Inc for corrective updates or replacement versions.
The recalled product
- Product
- MIM software; System, Image Processing, Radiological
- Manufacturer
- MIM Software Inc
- Affected units
- 352
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- Software versions: 1. MIM Anyware 1.1
- UDI/DI Not Applicable 2. MIM 7.2.0
- UDI/DI 00850009343192
- 3. MIM 7.2.1
- 4. MIM 7.2.2
- 5. MIM 7.2.3
- 6. MIM 7.2.4
- 7. MIM 7.2.5
- 8. MIM 7.2.6
Distribution
Distributed nationwide across the United States.
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