Shanghai United Imaging Healthcare Co., Ltd. No. 2258 Chengbei Rd, Jiading Ind. Shanghai China 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). Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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).
Brand
Shanghai United Imaging Healthcare Co., Ltd. No. 2258 Chengbei Rd, Jiading Ind. Shanghai China
Lot Codes / Batch Numbers
Serial Numbers: 3000162, 300163, 300174, 300176
Products Sold
Serial Numbers: 3000162, 300163, 300174, 300176
Shanghai United Imaging Healthcare Co., Ltd. No. 2258 Chengbei Rd, Jiading Ind. Shanghai China is recalling Computed Tomography X-Ray System, Model uCT 530, Rx, CE, GTIN: 06971576831012 - Product Usage: nten due to 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. . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026