The Recall Desk

Manufacturer

Shanghai United Imaging Healthcare Co., Ltd.

33 recalls in our database name Shanghai United Imaging Healthcare Co., Ltd. as the manufacturing or recalling firm.

What the numbers show

Total
33
Critical
0
Severe
0
Most recent
2026-10-07

Of the 33 recalls from Shanghai United Imaging Healthcare Co., Ltd. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

26–33 of 33

  • HighFDA (Devices)·Z-2704-2020·2020-08-05

    United Imaging uCT 530 CT System Recalled for Sharp Metal Edge

    Shanghai United Imaging Healthcare is recalling four uCT 530 Computed Tomography X-ray Systems because uneven metal edge overlap may create a sharp edge.

    Product
    Computed Tomography X-ray System; Model uCT 530; Rx; UDI: (01) GTIN: 06971576831012 - Product Usage: intended to produce cross-sectional images of the body using computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2705-2020·2020-08-05

    United Imaging uCT 550 CT Systems Recalled for Sharp Metal Edges

    Shanghai United Imaging Healthcare is recalling three uCT 550 Computed Tomography X-ray Systems because uneven metal edges on the mylar strip may create sharp edges.

    Product
    Computed Tomography X-ray System; Model uCT 550; Rx; UDI: (01) GTIN: 06971576831036 - Product Usage: intended to produce cross-sectional images of the body using computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2703-2020·2020-08-05

    United Imaging uCT 760 CT Systems Recalled for Sharp Metal Edges

    Shanghai United Imaging Healthcare is recalling five uCT 760 CT systems because uneven metal edges on the mylar strip may create sharp edges.

    Product
    Computed Tomography X-ray System; Model uCT 760; Rx; UDI: (01) GTIN: 06971576831043 - Product Usage: intended to produce cross-sectional images of the body using computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2641-2020·2020-07-29

    United Imaging uCT 550 CT System Recalled for Image Artifacts

    Shanghai United Imaging Healthcare is recalling three uCT 550 CT systems in Texas due to software issues that may cause image artifacts or scanning interruptions.

    Product
    Computed Tomography X-ray System, Model: uCT 550, GTIN: 06971576831036 Intended use The uCT Computed Tomography X-ray System uCT 530/uCT 550 is a computed tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of X-ray…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2521-2020·2020-07-15

    United Imaging Recalls uDR 596i Digital Medical X-Ray Imaging Systems

    Shanghai United Imaging Healthcare is recalling six uDR 596i digital medical X-ray systems due to software errors that may cause incorrect anatomical positioning or loss of image tags, leading to additional radiation exposure.

    Product
    uDR 596i Digital Medical X-Ray Imaging System - Product Usage: intended to use by a qualified/ trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, limbs and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2522-2020·2020-07-15

    United Imaging uCT 760 CT System Recalled for Image Artifacts

    Shanghai United Imaging Healthcare is recalling five uCT 760 CT systems due to intermittent image artifacts and scanning interruptions that may require patient rescans.

    Product
    uCT 760 System, Computed Tomography X-ray System
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2472-2020·2020-07-08

    United Imaging uCT 530 CT System Recalled for Scanning Interruptions

    Shanghai United Imaging Healthcare is recalling four uCT 530 Computed Tomography X-Ray Systems in Texas due to software issues that may cause scanning interruptions or image artifacts.

    Product
    uCT 530 Computed Tomography X-Ray System
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1708-2020·2020-04-22

    United Imaging uMI 550 PET/CT System Recalled for Software Bugs

    Shanghai United Imaging Healthcare is recalling two uMI 550 PET/CT systems due to software bugs that may cause reconstruction problems and patient rescans.

    Product
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide