Digital Medical X-ray Imaging System, Model: uDR 596i, uDR… recallZ-1075-2022 · Shanghai United Imaging Healthcare Co., Ltd. · initiated Jul 30, 2019
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Shanghai United Imaging Healthcare Co., Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Software change control
What the company is doing
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.
Recall details
- Recall number
- Z-1075-2022
- Status
- Terminated
- Initiated by the company
- Jul 30, 2019
- Recalling firm
- Shanghai United Imaging Healthcare Co., Ltd.
- Quantity
- 4
- Product code
- KPR
- FDA submissions
- K181413
- Distribution
- US Nationwide distribution in the state of TX.
Product description
Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h
Code information (models, lots, serial numbers)
DI/GTIN: 06971576833023, Serial Numbers: 270012, 270013,270014, 270015
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- uDR uDR 596iShanghai United Imaging Healthcare Co., Ltd. · Solid State X-Ray Imager (Flat Panel/Digital Imager)2 recalls0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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