Z-2704-2020Class II

Computed Tomography X-ray System; Model uCT 530; Rx; UDI: (01) GTIN: 06971576831012 -

Name: Z-2704-2020 Computed Tomography X-ray System; Model uCT 530; Rx; UDI: (01) GTIN: 06971576831012 -
Creator: Shanghai United Imaging Healthcare Co., Ltd.
Published: 2020-06-20
License: https://open.fda.gov/license/

Shanghai United Imaging Healthcare Co., Ltd. / initiated 2020-06-20 / Open, Classified / root cause: design

FDA source

Shanghai United Imaging Healthcare Co., Ltd. began a recall of Computed Tomography X-ray System; Model uCT 530; Rx; UDI: (01) GTIN: 06971576831012 - Product Usage: intended to produce cross-sectional images of the body... on 2020-06-20. FDA classified it as Class II and gives the reason as "The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2704-2020
Classification: Class II
Status: Open, Classified
Initiated: 2020-06-20
Posted: 2020-07-27
Recalling firm: Shanghai United Imaging Healthcare Co., Ltd.
Product: Computed Tomography X-ray System; Model uCT 530; Rx; UDI: (01) GTIN: 06971576831012 - 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).
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge.
Root cause tag: design
FDA 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 in commerce: 4
Distribution: US Nationwide distribution including in the states of CA, IN and TX. See uploaded distribution list for more details.
Product codes and lots: SN 300162, 300163, 300174, 300176

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2704-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2703-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-08-05	2020-07-27
Z-2704-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-08-05	2020-07-27
Z-2705-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-08-05	2020-07-27

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)