🔍 RecallPedia

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 body (including head, neck, cardiac, and vascular).

Class I - Dangerous
🏥 Medical Devices Recalled: June 20, 2020 Shanghai United Imaging Healthcare Co. Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    SN 300162, 300163, 300174, 300176
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Shanghai United Imaging Healthcare Co., Ltd.
Reason for Recall:
The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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 body (including head, neck, cardiac, and vascular).

Product Codes/Lot Numbers:

SN 300162, 300163, 300174, 300176

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2704-2020

Related Recalls

Positron Emission Tomography and Computed Tomography System, Model: uMI 550

Shanghai United Imaging Healthcare Co.

Class I - Dangerous

The wireless VSM module of a mobile PET/CT system, operating in an environment with strong Wi-Fi signals, may experience ECG signal and respiratory signal loss due to Wi-Fi interference. ECG and respiratory signal loss during acquisition can result in the failure of ECG and respiratory-gated reconstruction of the PET scan, which may require rescanning of the patient.

May 30, 2022 Other Medical Devices View Details →