Z-2641-2020Class II

Computed Tomography X-ray System, Model: uCT 550, GTIN: 06971576831036 Intended use The uCT Computed...

Name: Z-2641-2020 Computed Tomography X-ray System, Model: uCT 550, GTIN: 06971576831036 Intended use The uCT Computed...
Creator: Shanghai United Imaging Healthcare Co., Ltd.
Published: 2020-05-23
License: https://open.fda.gov/license/

Shanghai United Imaging Healthcare Co., Ltd. / initiated 2020-05-23 / Open, Classified / root cause: software

FDA source

Shanghai United Imaging Healthcare Co., Ltd. began a recall of 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... on 2020-05-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2641-2020
Classification: Class II
Status: Open, Classified
Initiated: 2020-05-23
Posted: 2020-07-20
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).
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: 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 tag: software
FDA 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 in commerce: 3
Distribution: US Distribution to state of: TX
Product codes and lots: Serial Numbers: 353020, 353021, and 353023 with software version R001.11.0.729741-Re-1100

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2641-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2641-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-07-29	2020-07-17

Product code JAK

K181414Class IIuCT 530, uCT 550Shanghai United Imaging Healthcare Co., Ltd. / cleared 2018-08-14

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)