FDA recall Z-2593-2021

Shanghai United Imaging Healthcare Co., Ltd. · Class II · device

Product

uMI 550 System - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.

Reason for recall

The EXAM acquisition workflow could occasionally freeze after canceling the PET scan.

Distribution

U.S. Nationwide distribution in the states of CA, IL, IN, TX, and WI.

Key facts

Status
Ongoing
Initiation date
2021-08-02
Report date
2021-10-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Shanghai, N/A, China

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2593-2021