The Recall Desk
HighFDA (Devices)·Z-0447-2021·Announced 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.

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 five units of the Computed Tomography X-Ray System, Model uCT 760. 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 display error 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 600229, 600230, 600232, 600271, and 600282.

Healthcare facilities should contact Shanghai United Imaging Healthcare Co., Ltd. for further instructions on how to address the issue with the affected equipment.

The recalled product

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
Manufacturer
Shanghai United Imaging Healthcare Co., Ltd.
Category
Medical Device — Imaging Equipment
Hazard
Affected units
5

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 (5)

  • Serial Numbers: 600229
  • 600230
  • 600232
  • 600271
  • 600282

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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