Recall Z-2521-2020 ยท KPR System, X-Ray, Stationary
Shanghai United Imaging Healthcare Co., Ltd.
uDR 596i Digital Medical X-Ray Imaging System - Product Usage: intended to use 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.
| Date | Feb 27, 2020 |
| Status | Terminated |
| Reason | Two issues were identified with the stationary x-ray system. 1. Some position illustrations in the patient exam interface show the incorrect anatomical position for the standard of care. When the image is acquired with the wrong reference position, clinical diagnostic requirements cannot be met.T2. Where image stitching is used, the left and right tag information may be lost. When these problems are encountered, an additional exposure is needed and the patient will receive more radiation. |
| Root cause | Software design |
| Action | The firm sent a Customer Notification Letter by email on February 27, 2020. The letter included identification of the serial numbers of devices affected by this issue. The firm's direct customers were instructed to identify users of the affected systems which have been installed. Customers were informed that they should not refer to illustrations showing the incorrect anatomical position for the standard of care, and that the impacted systems will be immediately remedied with a software hotfix on R002.19.0-4.8648-690113 software version via field software update. Customers with questions were |
| Quantity | 6 units |
| Distribution | US Nationwide distribution including in the state of Texas. |
| 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 |