Shanghai United Imaging Healthcare recalls uDR 596i X-ray systems with potential for uncommanded motion causing patient collisions. Affected units have specific serial numbers. Contact for remedy.
There is a potential for the X-Ray tube head (Touch screen interface) to perform an uncommanded motion. This could result in a collision with the patient.
Shanghai United Imaging Healthcare is recalling uDR 596i X-ray systems that may move unexpectedly during use, risking patient collisions. This is serious because it could cause injury during medical imaging procedures.
The X-ray tube head's touch screen interface may move unexpectedly without command. This uncontrolled motion could collide with the patient during imaging, potentially causing injury.
Qualified medical professionals using the uDR 596i X-ray system for diagnostic imaging on patients. Patients at risk during procedures involving the system.
Check for serial numbers 270012 through 270017 on the uDR 596i X-ray system. The product is intended for use by trained medical staff in diagnostic imaging.
Verify if your unit has serial numbers 270012 through 270017.
The product is intended for use by qualified medical staff, but there is a risk of uncommanded motion that could cause patient collisions. Do not use until you check the serial number.
Check if your unit has serial numbers 270012 through 270017. If so, contact the manufacturer for remedy instructions.
The manufacturer does not provide a remedy, so you should not use the product until you check the serial number and contact them.
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-1160-2021 — Shanghai United Imaging Healthcare Shanghai United Imaging Healthcare Hello, I own a Shanghai United Imaging Healthcare that is covered by recall Z-1160-2021 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.
