Official recall notice
Positron Emission Tomography Recall (Oct 2026)
Product: Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama 35 with software
- Recall date
- 2026-10-07
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.
Product description
Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.
Affected products
UDI-DI: 06971576832170. Serial Number: 11MI410003/R001.19.4.1909524, 11MI410004/R001.19.4.1909524, 11MI410005/R001.19.4.1909524, 20MI410001/R001.19.4.1909524, 20MI410002/R001.19.4.1909524, 20MI410003/R001.21.0.1993334, 20MI410004/R001.19.4.1909524