Shanghai United Imaging Healthcare recalls uDR 596i and uDR 592h X-ray systems due to reversed spine positioning labels, risking repeat patient exposures. Affected units have specific serial numbers and were sold with certain DI/GTIN codes.
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.
Shanghai United Imaging Healthcare is recalling two X-ray imaging systems (uDR 596i and uDR 592h) because their spine positioning labels are reversed. This could lead to incorrect images and repeat X-ray exposures for patients, which increases radiation risk.
The X-ray system labels for flexion and extension positions on the spine are reversed. This causes the images to be incorrectly labeled, potentially requiring the patient to undergo additional X-rays to correct the error.
Patients using these X-ray systems for spine imaging may face repeat exposures. Healthcare facilities that own or use the recalled models are most at risk.
Check for serial numbers 270012, 270013, 270014, or 270015 on the device. The product also has DI/GTIN code 06971576833023.
Look for the serial numbers 270012, 270013, 270014, or 270015 on the X-ray system.
The spine positioning labels on these X-ray systems are reversed, which can cause incorrect images and repeat X-ray exposures for patients.
Check for serial numbers 270012, 270013, 270014, or 270015 on the device. The product also has DI/GTIN code 06971576833023.
The recall record does not specify a remedy, so no action is required beyond checking if your device is affected.
We’ve drafted a message you can send Shanghai United Imaging Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1075-2022 — Shanghai United Imaging Healthcare Shanghai United Imaging Healthcare Hello, I own a Shanghai United Imaging Healthcare that is covered by recall Z-1075-2022 from Shanghai United Imaging Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
