medical Class II Updated 2020-08-19

Shanghai United Imaging Healthcare Co., Ltd. recalls uEXPLORER PET/CT Diagnostic Imaging System - Product Usage:

Recalled Product

uEXPLORER 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.


Hazard / Issue

1) 1) Potential intermittent issue may cause image data problems, may lead to 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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Serial No. F00002; GTIN 06971576832040
View official government recall

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