Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Positron Emission Tomography and Computed Tomography System Recalled by Shanghai United Imaging Healthcare Co., Ltd. Due to The wireless VSM module of a mobile PET/CT...
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
Positron Emission Tomography and Computed Tomography System, Model: uMI 550
Quantity: 32
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 4 states: CA, MI, TX, WI
About Shanghai United Imaging Healthcare Co., Ltd.
Shanghai United Imaging Healthcare Co., Ltd. has 21 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report