Recall Z-1075-2022 ยท KPR System, X-Ray, Stationary
Shanghai United Imaging Healthcare Co., Ltd.
Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h
| Date | Jul 30, 2019 |
| Status | Terminated |
| 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. |
| Root cause | Software change control |
| Action | On 07/30/19, Customer Notification Letters started being distributed to customers. Customers were asked to contact the firm if they found an inconsistency between the protocol name and the positioning image. The following phone numbers were provided: (855) 221-1552 (toll free) or (832) 699-2799 (direct). The firm issued Field Correction Instructions to Service Engineers to modify the protocol name of Flexion and Extension on C-Spine & L-Spine with the corrected guidelines. In addition, the firm committed to permanently fix impacted systems with a software update. |
| Quantity | 4 |
| 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 |