Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Shanghai United Imaging Healthcare Co. Recalled by Shanghai United Imaging Healthcare Co., Ltd. Due to Due to a software issue where the process...
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
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI 550 Part Number: 88000657 88000057
Quantity: 47 systems (U.S. only)
Why Was This Recalled?
Due to a software issue where the process of patient scanning, the scatter correction may occasionally fail with will potentially cause a failure of the PET image reconstruction and generation of PET images.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
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