Z-1160-2021Class II

Digitial Medica X-ray Imagining System, Model: uDR 596i, RX, CE0123, UDI:(01) 06971576833023 -

Name: Z-1160-2021 Digitial Medica X-ray Imagining System, Model: uDR 596i, RX, CE0123, UDI:(01) 06971576833023 -
Creator: Shanghai United Imaging Healthcare Co., Ltd.
Published: 2021-01-25
License: https://open.fda.gov/license/

Shanghai United Imaging Healthcare Co., Ltd. / initiated 2021-01-25 / Terminated / root cause: design

FDA source

Shanghai United Imaging Healthcare Co., Ltd. began a recall of Digitial Medica X-ray Imagining System, Model: uDR 596i, RX, CE0123, UDI:(01) 06971576833023 - Product Usage: intended to used by a qualified/trained doctor or... on 2021-01-25. FDA classified it as Class II and gives the reason as "There is a potential for the X-Ray tube head (Touch screen interface) to perform an uncommanded motion. This could result in a collision with the patient". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1160-2021
Classification: Class II
Status: Terminated
Initiated: 2021-01-25
Posted: 2021-03-02
Terminated: 2022-05-03
Recalling firm: Shanghai United Imaging Healthcare Co., Ltd.
Product: Digitial Medica X-ray Imagining System, Model: uDR 596i, RX, CE0123, UDI:(01) 06971576833023 - Product Usage: intended to used by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, limbs and trunk. Not for mammography.
Product code: KPR System, X-Ray, Stationary
Reason for recall: There is a potential for the X-Ray tube head (Touch screen interface) to perform an uncommanded motion. This could result in a collision with the patient.
Root cause tag: design
FDA root cause: Device Design
Action: On 01/25/2021, Shanghai United Imaging sent an Urgent: Medical Device Correction via: Email. In addition to informing consignees about the recall, the firm asked customers to take the following actions: 1. Once the RHA motor driver is powered on, and while the RHA motor is looking for the zero-position (before its first electric movements), please do not apply any external force to the TUI. 2. For further questions, please contact your United Imaging Service Engineer or call the United Imaging Customer Contact Center at our 24-hour hotline (855) 221-1552 (toll free) or (832) 699-2799 (direct). 3. Adverse reactions or quality problems experienced with the use of this product may be reported to FDAs MedWatch Adverse Event Reporting program either online, by regulatory mail or by fax. 4. Notify all users of the affected products via this Customer Notification Letter. 5. Please completed the Receipt of Customer Notification Letter form and return to United Imaging.
Quantity in commerce: 6 units
Distribution: US Nationwide distribution in the state of TX.
Product codes and lots: Serial Number: 270012, 270013, 270014, 270015, 270016, 270017

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1160-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1160-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-10	2021-03-02

Product code KPR

K181413Class IIuDR 592h, uDR 596iShanghai United Imaging Healthcare Co., Ltd. / cleared 2018-06-27

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)