Shanghai United Imaging Healthcare Co., Ltd. recalls

21 recalls on record · latest: March 1, 2023

Official U.S. recall history for Shanghai United Imaging Healthcare Co., Ltd., compiled from official government records.

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Shanghai United Imaging Healthcare Co., Ltd. recalls Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI…

March 1, 2023 · Medical device recalls Moderate risk Due to a software issue where the process of patient scanning, the scatter corr…

Shanghai United Imaging Healthcare Co., Ltd. recalls Positron Emission Tomography and Computed Tomography System, Model: uMI 550

May 30, 2022 · Medical device recalls Moderate risk The wireless VSM module of a mobile PET/CT system, operating in an environment…

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…

August 2, 2021 · Medical device recalls Moderate risk The EXAM acquisition workflow could occasionally freeze after canceling the PET…

Shanghai United Imaging Healthcare Co., Ltd. recalls uMI 550 System - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detectio…

August 2, 2021 · Medical device recalls Moderate risk The EXAM acquisition workflow could occasionally freeze after canceling the PET…

Shanghai United Imaging Healthcare Co., Ltd. recalls Digitial Medica X-ray Imagining System, Model: uDR 596i, RX, CE0123, UDI:(01) 06971576833023 - Product Usage: intended…

January 25, 2021 · Medical device recalls Moderate risk There is a potential for the X-Ray tube head (Touch screen interface) to perfor…

Shanghai United Imaging Healthcare Co., Ltd. recalls Positron Emission Tomography and Computed Tomography System, Model uMI 550, Rx, CE, GTIN: 06971576832026 - Product Usag…

August 5, 2020 · Medical device recalls Moderate risk A potential issue of an incorrect CT scan delay timer to be displayed on the ga…

Shanghai United Imaging Healthcare Co., Ltd. recalls Computed Tomography X-Ray System, Model uCT 760, Rx, CE, GTIN: 06971576831043 - Product Usage: ntended to produce cross…

August 5, 2020 · Medical device recalls Moderate risk A potential issue of an incorrect CT scan delay timer to be displayed on the ga…

Shanghai United Imaging Healthcare Co., Ltd. recalls Computed Tomography X-Ray System, Model uCT 550, Rx, CE, GTIN: 06971576831036 - Product Usage: ntended to produce cross…

August 5, 2020 · Medical device recalls Moderate risk A potential issue of an incorrect CT scan delay timer to be displayed on the ga…

Shanghai United Imaging Healthcare Co., Ltd. recalls Computed Tomography X-Ray System, Model uCT 530, Rx, CE, GTIN: 06971576831012 - Product Usage: ntended to produce cross…

August 5, 2020 · Medical device recalls Moderate risk A potential issue of an incorrect CT scan delay timer to be displayed on the ga…

Shanghai United Imaging Healthcare Co. product recalled over laceration hazard

July 16, 2020 · Medical device recalls Moderate risk 1) 1) Potential intermittent issue may cause image data problems, may lead to a…

Shanghai United Imaging Healthcare Co. product recalled over laceration hazard

July 16, 2020 · Medical device recalls Moderate risk 1) Service function problem may cause false marking of a bad channel resulting…

Computed Tomography X-ray System recalled over laceration hazard

June 20, 2020 · Medical device recalls Moderate risk The metal edge overlap of the mylar strip in the gantry was uneven, which may c…

Computed Tomography X-ray System recalled over laceration hazard

June 20, 2020 · Medical device recalls Moderate risk The metal edge overlap of the mylar strip in the gantry was uneven, which may c…

Computed Tomography X-ray System recalled over laceration hazard

June 20, 2020 · Medical device recalls Moderate risk The metal edge overlap of the mylar strip in the gantry was uneven, which may c…

Shanghai United Imaging Healthcare Co., Ltd. recalls Computed Tomography X-ray System, Model: uCT 550, GTIN: 06971576831036 Intended use The uCT Computed Tomography X-ray S…

May 23, 2020 · Medical device recalls Moderate risk Two issues were identified with the computed tomography x-ray system including…

Shanghai United Imaging Healthcare Co., Ltd. recalls uCT 530 Computed Tomography X-Ray System

May 8, 2020 · Medical device recalls Moderate risk Two issues were identified with the computed tomography x-ray system including…

Shanghai United Imaging Healthcare Co., Ltd. recalls uCT 760 System, Computed Tomography X-ray System

May 8, 2020 · Medical device recalls Moderate risk Two issues were identified with the computed tomography x-ray system including…

Shanghai United Imaging Healthcare Co., Ltd. recalls Positron Emission Tomography and Computed Tomography System, Model: uMI 550, Material Number: 88000057 - Product Usage:…

March 26, 2020 · Medical device recalls Moderate risk In affected software version, of Positron emission tomography and computed tomo…

Shanghai United Imaging Healthcare Co., Ltd. recalls uDR 596i Digital Medical X-Ray Imaging System - Product Usage: intended to use by a qualified/ trained doctor or techni…

February 27, 2020 · Medical device recalls Moderate risk Two issues were identified with the stationary x-ray system. 1. Some position i…

Shanghai United Imaging Healthcare Co., Ltd. recalls Positron Emission Tomograpy and Computed Tomography System, Model: uMI 550, with software version R001.3.0.0.750505, Rx…

August 26, 2019 · Medical device recalls Moderate risk Potential sporadic software bugs in R001.3.0.0.750505 software version may caus…

Shanghai United Imaging Healthcare Co., Ltd. recalls Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h

July 30, 2019 · Medical device recalls Moderate risk X-ray imaging system positioning image and protocol label is reversed for Flexi…