medical Class II Updated 2020-11-18

Shanghai United Imaging Healthcare Co., Ltd. recalls Positron Emission Tomography and Computed Tomography System,

Recalled Product

Positron Emission Tomography and Computed Tomography System, Model uMI 550, Rx, CE, GTIN: 06971576832026 - 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

A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. This could lead the operator to receive unnecessary exposure to radiation.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Serial Numbers: 200017, 200023, 200024, 200036, 200045, 200047, 230002, 230003, 230004
View official government recall

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