Z-1267-2025Class II

MIM software; System, Image Processing, Radiological

Name: Z-1267-2025 MIM software; System, Image Processing, Radiological
Creator: MIM Software Inc
Published: 2025-02-19
License: https://open.fda.gov/license/

MIM Software Inc / initiated 2025-02-19 / Open, Classified / root cause: software

FDA source

MIM Software Inc began a recall of MIM software; System, Image Processing, Radiological on 2025-02-19. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1267-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-02-19
Posted: 2025-03-04
Recalling firm: MIM Software Inc
Product: MIM software; System, Image Processing, Radiological
Product code: LLZ 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.
Root cause tag: software
FDA root cause: Software design
Action: GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 02/19/2025 disseminated using a traceable means. The notice explained the issue, potential risk to the patient, and provided the following actions to be taken to use the device: "You can continue to use your device if you are not using the SUV tool or if you access a non-impacted version of MIM when using the SUV tool. If using a non-default workflow and fusing a PET or SPECT image with another image with a different FOV, do not incorporate the Maximum SUV value into assessment of disease status, progression or response to treatment. NOTE: MIM s default workflows do not fuse images with differing FOV, and the Maximum SUV values reported are correct. If you are using the SUV tool and are unsure if you are affected by this issue, please contact your MIM Site Development Manager, your Distributor for MIM Software, or MIM Customer Support." "Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions."
Quantity in commerce: 352 units
Distribution: Worldwide distribution - United States Nationwide and the countries of Australia, Belgium, Bolivia, Canada, China, Croatia, Czech Republic, Denmark, France, Germany, Greece, Israel, Italy, Japan, Mexico, Netherlands, Poland, Russia, Spain, Sweden, United Kingdom, Finland, Hong Kong.
Product codes and lots: Software versions: 1. MIM Anyware 1.1, UDI/DI Not Applicable 2. MIM 7.2.0, UDI/DI 00850009343192; 3. MIM 7.2.1, UDI/DI 00850009343192; 4. MIM 7.2.2, UDI/DI 00850009343192; 5. MIM 7.2.3, UDI/DI 00850009343192; 6. MIM 7.2.4, UDI/DI 00850009343192; 7. MIM 7.2.5, UDI/DI 00850009343192; 8. MIM 7.2.6, UDI/DI 00850009343192

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1267-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1267-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-12	2025-03-04

Product code LLZ

K071964Class IIMim 4.1 (Seastar)Mimvista Corp. / cleared 2007-09-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)