Z-1075-2022Class II

Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h

Name: Z-1075-2022 Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h
Creator: Shanghai United Imaging Healthcare Co., Ltd.
Published: 2019-07-30
License: https://open.fda.gov/license/

Shanghai United Imaging Healthcare Co., Ltd. / initiated 2019-07-30 / Terminated / root cause: software

FDA source

Shanghai United Imaging Healthcare Co., Ltd. began a recall of Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h on 2019-07-30. FDA classified it as Class II and gives the reason as "X-ray imaging system positioning image and protocol label is reversed for Flexion and Extension on C-Spine and L-Spine, this will cause the image to be incorrectly labeled and may cause the patient to have a repeat...". 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-1075-2022
Classification: Class II
Status: Terminated
Initiated: 2019-07-30
Posted: 2022-05-12
Terminated: 2022-05-17
Recalling firm: Shanghai United Imaging Healthcare Co., Ltd.
Product: Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h
Product code: KPR System, X-Ray, Stationary
Reason for recall: X-ray imaging system positioning image and protocol label is reversed for Flexion and Extension on C-Spine and L-Spine, this will cause the image to be incorrectly labeled and may cause the patient to have a repeat exposure.
Root cause tag: software
FDA root cause: Software change control
Action: On 07/30/19, Customer Notification Letters started being distributed to customers. Customers were asked to contact the firm if they found an inconsistency between the protocol name and the positioning image. The following phone numbers were provided: (855) 221-1552 (toll free) or (832) 699-2799 (direct). The firm issued Field Correction Instructions to Service Engineers to modify the protocol name of Flexion and Extension on C-Spine & L-Spine with the corrected guidelines. In addition, the firm committed to permanently fix impacted systems with a software update.
Quantity in commerce: 4
Distribution: US Nationwide distribution in the state of TX.
Product codes and lots: DI/GTIN: 06971576833023, Serial Numbers: 270012, 270013,270014, 270015

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1075-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1075-2022	Class II	Terminated	Voluntary: Firm initiated	2022-05-18	2022-05-12

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)