FDA Medical Device Recalls (openFDA)
Shanghai United Imaging Healthcare Co., Ltd.: Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h
- Recall number
- Z-1075-2022
- Recalling firm
- Shanghai United Imaging Healthcare Co., Ltd.
- Product
- Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h
- Status
- Terminated
- Initiated
- 2019-07-30
- Posted
- not on file
- Terminated
- 2022-05-17
- Reason
- 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
- 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
- 4
- Distribution
- US Nationwide distribution in the state of TX.
- Lot, serial or model codes
- DI/GTIN: 06971576833023, Serial Numbers: 270012, 270013,270014, 270015
- 510(k) numbers
- ["K181413"]
- PMA numbers
- not on file
- Product code
- KPR
- Firm FEI
- 3011015597
- Firm city
- Shanghai
- Firm state
- not on file
- Firm country
- China
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28