Day

March 4, 2025
04
Mar

FDA Recall: Software Error Leading to Incorrect and Elevated Maximum Standardized Uptake Value

March 4, 2025
Company: MIM Software Inc Date of Enforcement Report: 3/04/2025 Class II PRODUCT MIM software; System, Image Processing, Radiological Recall Number: Z-1252-2025 REASON: 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. RECALLING FIRM/MANUFACTURER:...
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