The Recall Desk

FDA (Devices) recall action 86269

Shanghai United Imaging Healthcare Co., Ltd. recalled 4 products on 2020-11-18

The FDA (Devices) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2020-11-18
Critical
0
Units
23

Why these products were recalled

A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. This could lead the operator to receive unnecessary exposure to radiation.

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

1–4 of 4

  • HighFDA (Devices)··2020-11-18

    United Imaging uCT 550 CT Scanners Recalled for Timer Display Error

    Shanghai United Imaging Healthcare is recalling five uCT 550 CT scanners because an incorrect delay timer display may expose operators to unnecessary radiation.

    Product
    Computed Tomography X-Ray System, Model uCT 550, Rx, CE, GTIN: 06971576831036 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (inclu
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2020-11-18

    United Imaging uCT 760 CT Scanner Recalled for Timer Display Error

    Shanghai United Imaging Healthcare is recalling five uCT 760 CT scanners because a display error may cause operators to receive unnecessary radiation exposure.

    Product
    Computed Tomography X-Ray System, Model uCT 760, Rx, CE, GTIN: 06971576831043 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (inclu
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2020-11-18

    United Imaging uCT 530 CT Scanner Recalled for Incorrect Timer Display

    Shanghai United Imaging Healthcare Co., Ltd. is recalling four uCT 530 CT scanners because an incorrect delay timer may display, potentially exposing operators to unnecessary radiation.

    Product
    Computed Tomography X-Ray System, Model uCT 530, Rx, CE, GTIN: 06971576831012 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (inclu
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2020-11-18

    United Imaging uMI 550 PET/CT System Recalled for Incorrect CT Scan Delay Timer

    Shanghai United Imaging Healthcare is recalling nine uMI 550 PET/CT systems because an incorrect CT scan delay timer may display, potentially exposing operators to unnecessary radiation.

    Product
    Positron Emission Tomography and Computed Tomography System, Model uMI 550, Rx, CE, GTIN: 06971576832026 - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and
    Category
    Distribution
    2 states