Shanghai United Imaging Healthcare Co., Ltd.: 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.

Agency Publication Date: November 12, 2020

Affected Products

Product: Computed Tomography X-Ray System, Model uCT 530, Rx, CE, GTIN: 06971576831012 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, vascular).

Serial Numbers: 3000162, 300163, 300174, 300176

Product: Computed Tomography X-Ray System, Model uCT 550, Rx, CE, GTIN: 06971576831036 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, vascular).

Serial Numbers: 353020, 353021, 353023, 353045, 353049

Product: Computed Tomography X-Ray System, Model uCT 760, Rx, CE, GTIN: 06971576831043 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, vascular).

Serial Numbers: 600229, 600230, 600232, 600271, 600282

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.

Serial Numbers: 200017, 200023, 200024, 200036, 200045, 200047, 230002, 230003, 230004

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86269

Status: Active

Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.

Manufactured In: China

Units Affected: 4 products (4; 5; 5; 9)

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Sources: FDA iRES · Raw API Response

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Affected Products

Serial Numbers: 3000162, 300163, 300174, 300176

Serial Numbers: 353020, 353021, 353023, 353045, 353049

Serial Numbers: 600229, 600230, 600232, 600271, 600282

Serial Numbers: 200017, 200023, 200024, 200036, 200045, 200047, 230002, 230003, 230004