FDAAugust 26, 2019device
Positron Emission Tomograpy and Computed Tomography System, Model: uMI 550, with software version R001.3.0.0.750505, Rx Only, CE 0197, UDI: (01)06971576832026 - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, di...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Potential sporadic software bugs in R001.3.0.0.750505 software version may cause an issue with the PET acquisition raw data causing reconstruction problems during PET/CT scanning and could possibly cause rescans of patients with additional dose.
What to do
FDA enforcement status: Terminated
Brands named
shanghai united imaging healthcareshanghaishanghai united
UPCs
06971576832026
Recall history
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