medical Class II Updated 2021-10-06

Shanghai United Imaging Healthcare Co., Ltd. recalls uEXPLORER PET/CT System - Product Usage: intended to be oper

Recalled Product

uEXPLORER PET/CT 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.

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Model: 88000025 GTIN/UDI Code: 06971576832040 / 01 06971576832040 240 88000025 21 F00002 Serial Numbers: F00002
View official government recall

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