Recall Z-2703-2020 ยท JAK System, X-Ray, Tomography, Computed
Shanghai United Imaging Healthcare Co., Ltd.
Computed Tomography X-ray System; Model uCT 760; Rx; UDI: (01) GTIN: 06971576831043 - Product Usage: intended to produce cross-sectional images of the body using computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, cardiac, and vascular).
| Date | Jul 27, 2020 (initiated Jun 20, 2020) |
| Status | Open, Classified |
| Reason | The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge. |
| Root cause | Device Design |
| Action | A Customer Notification Letter was sent to the affected consignees on 06/20/2020 via email. United Imaging will replace the mylar strip with an improved one on the affected products via on-site update. On 8/30/2024, a correction notice was sent identifying an additional serial number. |
| Quantity | 5 units |
| Distribution | US Nationwide distribution including in the states of CA, IN and TX. See uploaded distribution list for more details. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172135 | uCT Computed Tomography X-ray System Shanghai United Imaging Healthcare Co., Ltd., Mar 2, 2018 |