FDA Medical Device Recalls (openFDA)
Shanghai United Imaging Healthcare Co., Ltd.: Computed Tomography X-ray System, Model: uCT 550, GTIN: 06971576831036 Intended use The uCT Computed Tomography X-ray System uCT 530/uCT 550 is a computed tomography X-ray system intended 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 and vascular).
- Recall number
- Z-2641-2020
- Recalling firm
- Shanghai United Imaging Healthcare Co., Ltd.
- Product
- Computed Tomography X-ray System, Model: uCT 550, GTIN: 06971576831036 Intended use The uCT Computed Tomography X-ray System uCT 530/uCT 550 is a computed tomography X-ray system intended 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 and vascular).
- Status
- Open, Classified
- Initiated
- 2020-05-23
- Posted
- 2020-07-20
- Terminated
- not on file
- Reason
- 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
- Software design
- Action
- On 05/23/2020, Customer Notification Letters dated 5/22/2020 were emailed to customers. Customers were asked to do the following: For safety issue 1: If you observe image artifacts, please reboot the system and continue the reconstruction. If the image artifacts persist, please contact the recalling firm's service support team or call the Customer Contact Center at (855) 221-1552 (toll free) or (832) 699-2799 (direct). For safety issue 2: If the scout scanning is interrupted, try repeating the scout scanning. If problem persists, please contact the recalling firm's service support team or call the Customer Contact Center at (855) 221-1552 (toll free) or (832) 699-2799 (direct). Customers were asked to notify all users of the affected products via Customer Notification Letter. On 8/30/2024, a correction notice was sent identifying an additional serial number.
- Quantity
- 3
- Distribution
- US Distribution to state of: TX
- Lot, serial or model codes
- Serial Numbers: 353020, 353021, and 353023 with software version R001.11.0.729741-Re-1100
- 510(k) numbers
- ["K181414"]
- 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