Shanghai United Imaging Healthcare Co., Ltd. recalls uMI 550 System - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detectio…

Recall date

August 2, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2593-2021

FDA classification

Class II

Brand / firm

Shanghai United Imaging Healthcare Co., Ltd.

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.