Computed Tomography X-ray System, Model: uCT 550, GTIN:… recallZ-2641-2020 · Shanghai United Imaging Healthcare Co., Ltd. · initiated May 23, 2020
Class II Open, Classified All recalls posted in July 2020
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Shanghai United Imaging Healthcare Co., Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Software design
What the company is doing
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.
Recall details
- Recall number
- Z-2641-2020
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- May 23, 2020
- Posted by the FDA
- Jul 20, 2020
- Recalling firm
- Shanghai United Imaging Healthcare Co., Ltd.
- Quantity
- 3
- Product code
- JAK
- FDA submissions
- K181414
- Distribution
- US Distribution to state of: TX
Product description
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).
Code information (models, lots, serial numbers)
Serial Numbers: 353020, 353021, and 353023 with software version R001.11.0.729741-Re-1100
Other devices under the same FDA submission
1 device cleared under K181414 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- uCT uCT 530Shanghai United Imaging Healthcare Co., Ltd. · System, X-Ray, Tomography, Computed3 recalls0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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