FDA recall Z-0223-2026

UIH Technologies LLC · Class II · device

Product

Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 550 MD, Rx Only

Reason for recall

Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.

Distribution

US: OUS:

Key facts

Status
Ongoing
Initiation date
2025-09-12
Report date
2025-10-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Houston, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0223-2026