The Recall Desk

FDA (Devices) recall action 85868

Shanghai United Imaging Healthcare Co., Ltd. recalled 3 products on 2020-08-05

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2020-08-05
Critical
0
Units
12

Why these products were recalled

The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge.

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

1–3 of 3

  • HighFDA (Devices)··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
    Distribution
    3 states
  • HighFDA (Devices)··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
    Distribution
    3 states
  • HighFDA (Devices)··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
    Distribution
    3 states