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 530 Computed Tomography X-Ray 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: Ongoing
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 530 Computed Tomography X-Ray System

Quantity: 4 units

Why Was This Recalled?

Two issues were identified with the computed tomography x-ray system including a service function which may cause false marking of a bad channel resulting in ring artifacts, and potential intermittent scout scanning interruption due to occasional angle signal drift.. If these problems occur, it may be necessary to rescan the patient resulting in an additional dose of radiation and the possible need for additional contrast medium.

Where Was This Sold?

Distributed to 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