Recall Z-1267-2025— MIM Software Inc

Name: FDA recall Z-1267-2025
Creator: U.S. Food and Drug Administration
Published: 2025-02-19

Class II · Ongoing

Class II FDA medical device recall by MIM Software Inc, initiated 2025-02-19. It names one FDA 510(k) clearance: K071964. Product: MIM software; System, Image Processing, Radiological. 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: MIM Software Inc
Classification: Class II
Status: Ongoing
Initiated: 2025-02-19
Firm location: Cleveland, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K071964 — MIM 4.1 (SEASTAR)Mimvista Corp.·cleared 2007-09-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

MIM software; System, Image Processing, Radiological

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.