FDAJuly 16, 2020device
uMI 550 PET/CT Diagnostic Imaging System - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but n...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
1) Service function problem may cause false marking of a bad channel resulting in ring artifacts; 2) Potential intermittent scout scanning interruption due to angle signal drift caused by external interference; 3) Metal edge overlap of mylar strip in gantry may create sharp edge. May lead to repeat scanning and abrasions (N/A for Serial No. 200036)
What to do
FDA enforcement status: Terminated
Brands named
shanghai united imaging healthcareshanghaishanghai united
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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