Official recall notice
Positron Emission Tomography Recall (Oct 2026)
Product: Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo 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: 06971576832231. Serial Number/Software: 11MI500004/R002.4.0.1872339, 11MI500005/R002.4.0.1872339, 11MI500006/R002.4.0.1872339