The Recall Desk

FDA (Devices) recall action 88521

Shanghai United Imaging Healthcare Co., Ltd. recalled 2 products on 2021-10-06

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
2021-10-06
Critical
0
Units
24

Why these products were recalled

The EXAM acquisition workflow could occasionally freeze after canceling the PET scan.

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

  • ModerateFDA (Devices)··2021-10-06

    uEXPLORER PET/CT System Workflow Freeze Recall

    The uEXPLORER PET/CT System is being recalled because the EXAM acquisition workflow may freeze after canceling a PET scan. Affected systems may experience workflow interruptions during diagnostic imaging.

    Product
    uEXPLORER PET/CT System - Product Usage: 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 not limit to, on
    Category
    Distribution
    5 states
  • ModerateFDA (Devices)··2021-10-06

    uMI 550 PET Imaging System Software Workflow May Occasionally Freeze

    The uMI 550 medical imaging system may occasionally freeze during the EXAM acquisition workflow when a PET scan is canceled. This can disrupt clinical operations.

    Product
    uMI 550 System - Product Usage: 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 not limit to, oncology, c
    Category
    Distribution
    5 states