Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h
Reported: May 18, 2022 Initiated: July 30, 2019 #Z-1075-2022
Product Description
Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h
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.
Details
- Recalling Firm
- Shanghai United Imaging Healthcare Co., Ltd.
- Units Affected
- 4
- Distribution
- US Nationwide distribution in the state of TX.
- Location
- Shanghai, N/A
Frequently Asked Questions
What product was recalled? ▼
Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h. Recalled by Shanghai United Imaging Healthcare Co., Ltd.. Units affected: 4.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 18, 2022. Severity: Moderate. Recall number: Z-1075-2022.
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