Z-2472-2020Class II

uCT 530 Computed Tomography X-Ray System

Name: Z-2472-2020 uCT 530 Computed Tomography X-Ray System
Creator: Shanghai United Imaging Healthcare Co., Ltd.
Published: 2020-05-08
License: https://open.fda.gov/license/

Shanghai United Imaging Healthcare Co., Ltd. / initiated 2020-05-08 / Open, Classified / root cause: software

FDA source

Shanghai United Imaging Healthcare Co., Ltd. began a recall of uCT 530 Computed Tomography X-Ray System on 2020-05-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2472-2020
Classification: Class II
Status: Open, Classified
Initiated: 2020-05-08
Posted: 2020-06-30
Recalling firm: Shanghai United Imaging Healthcare Co., Ltd.
Product: uCT 530 Computed Tomography X-Ray System
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software design
Action: The firm sent letters to their customers by email on 5-22-2020. The letter informs customers of the two potential safety issues with the device, and notes that these problems may cause image artifacts and scanning workflow interruptions. Risks to patient health are noted to include the possible need to rescan the patient resulting in an additional radiation dose and the possible need for additional contrast medium. Customers were informed that United Imaging has released a field update for the uCT 530 to address the issues. If customers observe image artifacts, they are requested to reboot the system and continue the reconstruction. If the scout scanning is interrupted, customers are instructed to try repeating the scout scanning. If problems persist, customers should contact their United Imaging service support team or call the United Imaging Customer Contact Center at (855) 221-1552 (toll free) or (832) 699-2799 (direct).
Quantity in commerce: 4 units
Distribution: Distributed to Texas.
Product codes and lots: Units with software version no. R001.11.0.729741-Re-1100 including the following: Serial number/GTIN: 300162 (GTIN: 6971576831012); 300163 (GTIN: 6971576831012); 300174 (GTIN: 6971576831012); and 300176 (GTIN: 6971576831012).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2472-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2472-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-07-08	2020-06-30

Product code JAK

K181414Class IIuCT 530, uCT 550Shanghai United Imaging Healthcare Co., Ltd. / cleared 2018-08-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)