Shanghai United Imaging Healthcare Co., Ltd. Recall 90104
Description: Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h
Shanghai United Imaging Healthcare Co., Ltd. Recall 90104 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1075-2022 |
| Event ID | 90104 |
| Event Description | Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the state of TX. |
| Quantity | 4 |
| Recall Reason | 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. |
| Device Classification | 20220518 |
| Device Code Info | DI/GTIN: 06971576833023, Serial Numbers: 270012, 270013,270014, 270015 |
| Center Classification Date | 20220512 |
| Recall Initiation Date | 20190730 |
| Recalling Firm | Shanghai United Imaging Healthcare Co., Ltd. |
| Initial Notification | Letter |
| Similar To |