Shanghai United Imaging Healthcare Co. product recalled over laceration hazard

Recall date

July 16, 2020

Source

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

Official notice title

Shanghai United Imaging Healthcare Co., Ltd. recalls uMI 550 PET/CT Diagnostic Imaging System - Product Usage: This system is intended to be operated by qualified healthcar…

Recall number

Z-2800-2020

FDA classification

Class II

Brand / firm

Shanghai United Imaging Healthcare Co., Ltd.

Sold / distributed

US Nationwide distribution including in the state of Texas.

Why it was recalled

1) Service function problem may cause false marking of a bad channel resulting in ring artifacts; 2) Potential intermittent scout scanning interruption due to angle signal drift caused by external interference; 3) Metal edge overlap of mylar strip in gantry may create sharp edge. May lead to repeat scanning and abrasions (N/A for Serial No. 200036)

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 PET/CT Diagnostic Imaging System - Product Usage: This system is 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.