Shanghai United Imaging Healthcare Co., Ltd.: Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h

Is my product affected?

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

• UPC 06971576833023

Check against the official notice below — it lists the full affected range.

What happened

Shanghai United Imaging Healthcare Co., Ltd. has recalled its Digital Medical X-ray Imaging System models uDR 596i and uDR 592h due to a labeling error affecting spinal imaging. The system incorrectly reverses the positioning image and protocol labels for Flexion and Extension views on cervical and lumbar spine scans, causing images to be mislabeled. This labeling error may result in patients requiring repeat X-ray exposure to obtain properly labeled images.

Four units of this system were distributed nationwide in Texas. The affected serial numbers are 270012, 270013, 270014, and 270015 (GTIN: 06971576833023). The source does not specify a remedy for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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 from the source

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. Distribution: US Nationwide distribution in the state of TX. Quantity: 4 Lot/code info: DI/GTIN: 06971576833023, Serial Numbers: 270012, 270013,270014, 270015

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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