FDA Medical Device Recalls (openFDA)
Shanghai United Imaging Healthcare Co., Ltd.: Computed Tomography X-ray System; Model uCT 550; Rx; UDI: (01) GTIN: 06971576831036 - Product Usage: intended to produce cross-sectional images of the body using computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, cardiac, and vascular).
- Recall number
- Z-2705-2020
- Recalling firm
- Shanghai United Imaging Healthcare Co., Ltd.
- Product
- Computed Tomography X-ray System; Model uCT 550; Rx; UDI: (01) GTIN: 06971576831036 - Product Usage: intended to produce cross-sectional images of the body using computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, cardiac, and vascular).
- Status
- Open, Classified
- Initiated
- 2020-06-20
- Posted
- 2020-07-27
- Terminated
- not on file
- Reason
- The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge.
- Root cause
- Device Design
- Action
- A Customer Notification Letter was sent to the affected consignees on 06/20/2020 via email. United Imaging will replace the mylar strip with an improved one on the affected products via on-site update. On 8/30/2024, a correction notice was sent identifying an additional serial number.
- Quantity
- 3
- Distribution
- US Nationwide distribution including in the states of CA, IN and TX. See uploaded distribution list for more details.
- Lot, serial or model codes
- SN 353020, 353021, 353023
- 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