Z-2522-2020Class II

uCT 760 System, Computed Tomography X-ray System

Name: Z-2522-2020 uCT 760 System, 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 / Terminated / root cause: software

FDA source

Shanghai United Imaging Healthcare Co., Ltd. began a recall of uCT 760 System, 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 an intermittent issue which may affect image data leading to artifacts; and intermittent scout scanning interruption due to occasional angle...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2522-2020
Classification: Class II
Status: Terminated
Initiated: 2020-05-08
Posted: 2020-07-10
Terminated: 2022-01-20
Recalling firm: Shanghai United Imaging Healthcare Co., Ltd.
Product: uCT 760 System, 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 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.
Root cause tag: software
FDA root cause: Software design
Action: Customers were sent emails on 05/22/2020 notifying them of the failure modes and the potential safety issues. Customers were informed that If image artifacts occur, it may be necessary for the user to repeat the examination. The rescan of the patient will result in an additional dose and the possible need for additional contrast medium. Customers were also informed that if the scout scanning is unexpectedly interrupted, it may be necessary for the user to repeat the scout scanning, resulting in an additional dose. Customers observing image artifacts were instructed to reboot the system and continue the reconstruction, and, if image artifacts persist, to 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). Similarly, if scout scanning is interrupted, customers were instructed to attempt repeating the scout and to contact the service support team if the problem continues. The email informs customers that United Imaging has released updated software R001.11.0.820958-Re-1150SP1+H1H2 to solve the intermittent issue and to eliminate angulation signal drift, which could eliminate the resulting image artifacts and scout scanning interruption, and to accomplish other improvements. Customers with further questions should contact the United Imaging Customer Contact Center at {855) 221-1552 {toll free) or {832) 699-2799 {direct).
Quantity in commerce: 5 units
Distribution: Distributed to two customers. Both customers located in Houston, Texas.
Product codes and lots: Model uCT 760; Serial Numbers: 600229, 600230, 600232, 600271 with software version R001.11.0.729741-Re-1100, and serial number 600282 with software version R001.11.0.785930-Re-1150.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2522-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2522-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-15	2020-07-06

Product code JAK

K172135Class IIuCT Computed Tomography X-ray SystemShanghai United Imaging Healthcare Co., Ltd. / cleared 2018-03-02

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)