FDAMarch 1, 2023device
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI 550 Part Number: 88000657 88000057
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
shanghai united imaging healthcareshanghaishanghai united
Recall history
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