Reported Mar 10, 2021 · Terminated
Digitial Medica X-ray Imagining System, Model: uDR 596i, RX, CE0123, UDI:(01) 06971576833023 - Product Usage: intended…
Shanghai United Imaging Healthcare Co., Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Shanghai United Imaging Healthcare Co., Ltd. · No. 2258 Chengbei Rd, Jiading Ind. · Shanghai · N/A
Is this the product you have?
- Digitial Medica X-ray Imagining System
- Model
uDR 596iRXCE0123
- UDI(01) 06971576833023 -
- Product Usageintended to used by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, limbs and trunk. Not for mammography
- Lot codes and dates
- Serial Number
270012270013270014270015270016270017
- Serial Number
- Amount recalled
- 6 units
Where it was sold
- Nationwide
- TX
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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