Shanghai United Imaging Healthcare Co., Ltd.: 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).

Recall number

Z-0447-2021

Recalling firm

Shanghai United Imaging Healthcare Co., Ltd.

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).

Status

Open, Classified

Initiated

2020-08-05

Posted

not on file

Terminated

not on file

Reason

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.

Root cause

Software design

Action

The firm sent notification letters via email to distributorsThe firm's consignee hand delivered a written Field Safety Notification to end-users on June 11, 2020 to inform them that the delay time displayed on the DDP can be incorrect for a timed scan such as a multi-phase contrast scan. The DDP is located on the gantry in the scan room. If the operator enters the scan room to perform any multi-phase contrast scan and refers to the incorrect delay time displayed on the DDP, he or she may not be able to leave the scan room before the scan starts, and as a result may receive unnecessary radiation dose. The letter states the following: The purpose of this letter is to advise you that United Imaging is voluntarily correcting some of the uCT 530, uCT 550, uCT 760 The uCT 530 and uMI 550 devices. Reason for the Voluntary Correction: We are aware of one complaint associated with the device. We have not received any report that have resulted in injury. Safety 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. Risk to Health of Safety Issue: The delay time displayed on the DDP can be incorrect for a timed scan such as a multi-phase contrast scan. The DDP is located on the gantry in the scan room. If the operator enters the scan room to perform any multi-phase contrast scan and refers to the incorrect delay time displayed on the DDP, he or she may not be able to leave the scan room before the scan starts, and as a result may receive unnecessary radiation dose. Actions to be taken by the Customer I User: 1. During a multi-phase contrast scan, do not perform any operations on the Preview image of any previous phases. 2. If possible, avoid entering the scan room when performing multi-phase contrast scans. 3. If it is necessary to enter the scan room when performing a multi-phase contrast scan, ignore the potentially incorrect delay time displayed on the

Quantity

5

Distribution

US Nationwide distribution including in the state of TX.

Lot, serial or model codes

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

510(k) numbers

["K172135"]

PMA numbers

not on file

Product code

JAK

Firm FEI

3011015597

Firm city

Shanghai

Firm state

not on file

Firm country

China

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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