Shanghai United Imaging Healthcare recalls
5 official recalls and safety alerts involving Shanghai United Imaging Healthcare since 2021-10, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Shanghai United Imaging Healthcare or the relevant agency.
- 2026-10-07
USShanghai United Imaging Healthcare Co., Ltd. recalls Computed Tomography X-ray System, Model: uCT 530 with software
Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images…
FDA · DeviceShanghai United Imaging Healthcare Co., Ltd.US Nationwide distribution in the states of CA, PR, UT, WV, ND, NE, NC, TX,…Official notice →- 2023-04-19
- US
Shanghai United Imaging Healthcare Co., Ltd. recalls Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model…
Due to a software issue where the process of patient scanning, the scatter correction may occasionally fail with will potentially cause a failure of the PET image reconstruction and generation of PET images.
FDA · DeviceShanghai United Imaging Healthcare Co., Ltd.U.S. Nationwide distribution in the state of TX. O.U.S.: Not provided.Official notice → - 2022-10-19
- US
Shanghai United Imaging Healthcare Co., Ltd. recalls Positron Emission Tomography and Computed Tomography System, Model: uMI 550
The wireless VSM module of a mobile PET/CT system, operating in an environment with strong Wi-Fi signals, may experience ECG signal and respiratory signal loss due to Wi-Fi interference. ECG and respiratory signal loss…
FDA · DeviceShanghai United Imaging Healthcare Co., Ltd.Distribution to US states of TX, WI, CA, and MIOfficial notice → - 2022-05-18
- US
Shanghai United Imaging Healthcare Co., Ltd. recalls Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h
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…
FDA · DeviceShanghai United Imaging Healthcare Co., Ltd.US Nationwide distribution in the state of TX.Official notice → - 2021-10-06
- US
Shanghai United Imaging Healthcare Co., Ltd. recalls uEXPLORER PET/CT System - Product Usage: intended to be operated by qualified healthcare professionals to assist in…
The EXAM acquisition workflow could occasionally freeze after canceling the PET scan.
FDA · DeviceShanghai United Imaging Healthcare Co., Ltd.U.S. Nationwide distribution in the states of CA, IL, IN, TX, and WI.Official notice →