Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

uCT 760 System Recalled by Shanghai United Imaging Healthcare Co., Ltd. Due to Two issues were identified with the computed tomography...

Date: May 8, 2020
Company: Shanghai United Imaging Healthcare Co., Ltd.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Shanghai United Imaging Healthcare Co., Ltd. directly.

Affected Products

uCT 760 System, Computed Tomography X-ray System

Quantity: 5 units

Why Was This Recalled?

Two issues were identified with the computed tomography x-ray system including an intermittent issue which may affect image data leading to artifacts; and intermittent scout scanning interruption due to occasional angle signal drift. This may result in the need for rescanning of the patient with the patient receiving an additional dose of radiation and possible use of additional contrast media.

Where Was This Sold?

Distributed to two customers. Both customers located in Houston, Texas.

About Shanghai United Imaging Healthcare Co., Ltd.

Shanghai United Imaging Healthcare Co., Ltd. has 21 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report