FDA Medical Device Recalls (openFDA)
Shanghai United Imaging Healthcare Co., Ltd.: uCT 760 System, Computed Tomography X-ray System
- Recall number
- Z-2522-2020
- Recalling firm
- Shanghai United Imaging Healthcare Co., Ltd.
- Product
- uCT 760 System, Computed Tomography X-ray System
- Status
- Terminated
- Initiated
- 2020-05-08
- Posted
- not on file
- Terminated
- 2022-01-20
- Reason
- 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
- 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
- 5 units
- Distribution
- Distributed to two customers. Both customers located in Houston, Texas.
- Lot, serial or model codes
- 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.
- 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
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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