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Shanghai United Imaging Healthcare Co., Ltd. recalls uMI 550 System - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection
Recalled October 6, 2021 · FDA recall Z-2593-2021 · Shanghai United Imaging Healthcare
Hazard
The EXAM acquisition workflow could occasionally freeze after canceling the PET scan. · FDA Class II
Units
23 systems
Sold at
U.S. Nationwide distribution in the states of CA, IL, IN, TX, and WI.
Description
The EXAM acquisition workflow could occasionally freeze after canceling the PET scan.
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.
Manufacturer(s)
Shanghai United Imaging Healthcare Co., Ltd.
Made in
China
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →