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Shanghai United Imaging Healthcare Co., Ltd. FDA Recalls
5 recalls on file across devices, 0 of them Class I and 4 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI Class IIMar 1, 2023Due to a software issue where the process of patient scannin |
| Positron Emission Tomography and Computed Tomography System, Model: uMI 550Class IIMay 30, 2022The wireless VSM module of a mobile PET/CT system, operating |
| uEXPLORER PET/CT System - Product Usage: intended to be operated by qualified healthcare professionals to assist in the Class IIAug 2, 2021The EXAM acquisition workflow could occasionally freeze afte |
| uMI 550 System - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detectionClass IIAug 2, 2021The EXAM acquisition workflow could occasionally freeze afte |
| Digitial Medica X-ray Imagining System, Model: uDR 596i, RX, CE0123, UDI:(01) 06971576833023 - Product Usage: intended tClass IIJan 25, 2021There is a potential for the X-Ray tube head (Touch screen |