The Recall Desk
HighFDA (Devices)·Z-0445-2021·Announced 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.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (radiation exposure) where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Shanghai United Imaging Healthcare Co., Ltd. is recalling four units of the Computed Tomography X-Ray System, Model uCT 530. The recall is due to a potential issue where an incorrect CT scan delay timer may be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning.

This malfunction could lead the operator to receive unnecessary exposure to radiation. The affected units were distributed nationwide in the United States, including in the state of Texas. The specific serial numbers for the recalled units are 3000162, 300163, 300174, and 300176.

Healthcare facilities should contact the manufacturer to verify if their equipment is affected and to arrange for the necessary corrective actions.

The recalled product

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
Manufacturer
Shanghai United Imaging Healthcare Co., Ltd.
Category
Medical Device — Imaging Equipment
Hazard
Affected units
4

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Serial Numbers: 3000162
  • 300163
  • 300174
  • 300176

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Shanghai United Imaging Healthcare Co., Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Related recalls

Same manufacturer · Shanghai United Imaging Healthcare Co., Ltd.

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Same hazard · radiation exposure

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