Shanghai United Imaging Healthcare Co., Ltd. Recall 87289
Description: Digitial Medica X-ray Imagining System, Model: uDR 596i, RX, CE0123, UDI:(01) 06971576833023 - Product Usage: intended 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.
Shanghai United Imaging Healthcare Co., Ltd. Recall 87289 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1160-2021 |
| Event ID | 87289 |
| Event Description | Digitial Medica X-ray Imagining System, Model: uDR 596i, RX, CE0123, UDI:(01) 06971576833023 - Product Usage: intended 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. |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the state of TX. |
| Quantity | 6 units |
| Recall Reason | 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. |
| Device Classification | 20210310 |
| Device Code Info | Serial Number: 270012, 270013, 270014, 270015, 270016, 270017 |
| Center Classification Date | 20210302 |
| Recall Initiation Date | 20210125 |
| Recalling Firm | Shanghai United Imaging Healthcare Co., Ltd. |
| Initial Notification | |
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