Recall Z-1160-2021 ยท KPR System, X-Ray, Stationary
Shanghai United Imaging Healthcare Co., Ltd.
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.
| Date | Jan 25, 2021 |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | On 01/25/2021, Shanghai United Imaging sent an Urgent: Medical Device Correction via: Email. In addition to informing consignees about the recall, the firm asked customers to take the following actions: 1. Once the RHA motor driver is powered on, and while the RHA motor is looking for the zero-position (before its first electric movements), please do not apply any external force to the TUI. 2. For further questions, please contact your United Imaging Service Engineer or call the United Imaging Customer Contact Center at our 24-hour hotline (855) 221-1552 (toll free) or (832) 699-2799 (direc |
| Quantity | 6 units |
| Distribution | US Nationwide distribution in the state of TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181413 | uDR 592h, uDR 596i Shanghai United Imaging Healthcare Co., Ltd., Jun 27, 2018 |