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All Recalls

Every Shanghai United Imaging Healthcare Co., Ltd. Recall

Sorted by most recent. Click any recall for full details.

12 recalls
High RiskFDA
Shanghai United Imaging Healthcare Co., Ltd.
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI 550 Part Number:...
Medical Devices·47 affected·Mar 1, 2023
High RiskFDA
Shanghai United Imaging Healthcare Co., Ltd.
Positron Emission Tomography and Computed Tomography System, Model: uMI 550
Medical Devices·32 affected·May 30, 2022
High RiskFDA
Shanghai United Imaging Healthcare Co., Ltd.
uEXPLORER PET/CT System - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, locali...
Medical Devices·1 affected·Aug 2, 2021
High RiskFDA
Shanghai United Imaging Healthcare Co., Ltd.
Positron Emission Tomography and Computed Tomography System, Model uMI 550, Rx, CE, GTIN: 06971576832026 - Product Usage: intended to be...
Medical Devices·9 affected·Aug 5, 2020
High RiskFDA
Shanghai United Imaging Healthcare Co., Ltd.
Computed Tomography X-Ray System, Model uCT 760, Rx, CE, GTIN: 06971576831043 - Product Usage: ntended to produce cross-sectional images...
Medical Devices·5 affected·Aug 5, 2020
High RiskFDA
Shanghai United Imaging Healthcare Co., Ltd.
Computed Tomography X-Ray System, Model uCT 550, Rx, CE, GTIN: 06971576831036 - Product Usage: ntended to produce cross-sectional images...
Medical Devices·5 affected·Aug 5, 2020
High RiskFDA
Shanghai United Imaging Healthcare Co., Ltd.
Computed Tomography X-Ray System, Model uCT 530, Rx, CE, GTIN: 06971576831012 - Product Usage: ntended to produce cross-sectional images...
Medical Devices·4 affected·Aug 5, 2020
High RiskFDA
Shanghai United Imaging Healthcare Co., Ltd.
uEXPLORER PET/CT Diagnostic Imaging System - Product Usage: This system is intended to be operated by qualified healthcare professionals ...
Diagnostic Devices·1 affected·Jul 16, 2020
High RiskFDA
Shanghai United Imaging Healthcare Co., Ltd.
Computed Tomography X-ray System; Model uCT 530; Rx; UDI: (01) GTIN: 06971576831012 - Product Usage: intended to produce cross-sectional...
Cardiac Devices·4 affected·Jun 20, 2020
High RiskFDA
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...
Cardiac Devices·5 affected·Jun 20, 2020
High RiskFDA
Shanghai United Imaging Healthcare Co., Ltd.
Positron Emission Tomography and Computed Tomography System, Model: uMI 550, Material Number: 88000057 - Product Usage: This system is in...
Medical Devices·3 affected·Mar 26, 2020
High RiskFDA
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 adul...
Diagnostic Devices·6 affected·Feb 27, 2020