The Recall Desk

FDA (Devices) recall action 85948

Shanghai United Imaging Healthcare Co., Ltd. recalled 2 products on 2020-08-19

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2020-08-19
Critical
0
Units
5

Why these products were recalled

1) 1) Potential intermittent issue may cause image data problems, may lead to 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.

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)

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2020-08-19

    United Imaging Recalls uEXPLORER PET/CT System for Potential Sharp Edges

    Shanghai United Imaging Healthcare is recalling one uEXPLORER PET/CT Diagnostic Imaging System in Texas due to potential sharp edges and image data issues.

    Product
    uEXPLORER 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
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2020-08-19

    United Imaging Recalls uMI 550 PET/CT Systems Due to Imaging and Safety Defects

    Shanghai United Imaging Healthcare is recalling four uMI 550 PET/CT systems due to defects that may cause image artifacts, scanning interruptions, or sharp edges.

    Product
    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 di
    Category
    Distribution
    2 states