Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

uEXPLORER PET/CT System - Product Usage: intended to be operated Recalled by Shanghai United Imaging Healthcare Co., Ltd. Due to The EXAM acquisition workflow could occasionally freeze after...

Date: August 2, 2021
Company: Shanghai United Imaging Healthcare Co., Ltd.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Shanghai United Imaging Healthcare Co., Ltd. directly.

Affected Products

uEXPLORER PET/CT System - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.

Quantity: 1 system

Why Was This Recalled?

The EXAM acquisition workflow could occasionally freeze after canceling the PET scan.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Shanghai United Imaging Healthcare Co., Ltd.

Shanghai United Imaging Healthcare Co., Ltd. has 21 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report