Z-2521-2020Class II

uDR 596i Digital Medical X-Ray Imaging System -

Name: Z-2521-2020 uDR 596i Digital Medical X-Ray Imaging System -
Creator: Shanghai United Imaging Healthcare Co., Ltd.
Published: 2020-02-27
License: https://open.fda.gov/license/

Shanghai United Imaging Healthcare Co., Ltd. / initiated 2020-02-27 / Terminated / root cause: software

FDA source

Shanghai United Imaging Healthcare Co., Ltd. began a recall of uDR 596i Digital Medical X-Ray Imaging System - Product Usage: intended to use by a qualified/ trained doctor or technician on both adult and pediatric... on 2020-02-27. FDA classified it as Class II and gives the reason as "Two issues were identified with the stationary x-ray system. 1. Some position illustrations in the patient exam interface show the incorrect anatomical position for the standard of care. When the image is acquired with...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2521-2020
Classification: Class II
Status: Terminated
Initiated: 2020-02-27
Posted: 2020-07-08
Terminated: 2021-05-28
Recalling firm: Shanghai United Imaging Healthcare Co., Ltd.
Product: uDR 596i Digital Medical X-Ray Imaging System - Product Usage: intended to use 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.
Product code: KPR System, X-Ray, Stationary
Reason for recall: Two issues were identified with the stationary x-ray system. 1. Some position illustrations in the patient exam interface show the incorrect anatomical position for the standard of care. When the image is acquired with the wrong reference position, clinical diagnostic requirements cannot be met.T2. Where image stitching is used, the left and right tag information may be lost. When these problems are encountered, an additional exposure is needed and the patient will receive more radiation.
Root cause tag: software
FDA root cause: Software design
Action: The firm sent a Customer Notification Letter by email on February 27, 2020. The letter included identification of the serial numbers of devices affected by this issue. The firm's direct customers were instructed to identify users of the affected systems which have been installed. Customers were informed that they should not refer to illustrations showing the incorrect anatomical position for the standard of care, and that the impacted systems will be immediately remedied with a software hotfix on R002.19.0-4.8648-690113 software version via field software update. Customers with questions were instructed to call (855) 221-1552 (toll free) or (832) 699-2799 (direct).
Quantity in commerce: 6 units
Distribution: US Nationwide distribution including in the state of Texas.
Product codes and lots: Model Number uDR 596i with software versions R002.19.0-1.8402-690106 and R002.19.0.8648.690112. Serial numbers: 270012, 270013, 270014, 270015, 270016 and 270017. UDI numbers: (01)06971576833023(240)88000093(21)270012; (01)06971576833023(240)88000093(21)270013; (01)06971576833023(240)88000093(21)270014; (01)06971576833023(240)88000093(21)270015; XXX; and XXX.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2521-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2521-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-15	2020-07-06

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)