uEXPLORER PET/CT System Workflow Freeze Recall
The uEXPLORER PET/CT System is being recalled because the EXAM acquisition workflow may freeze after canceling a PET scan. Affected systems may experience workflow interruptions during diagnostic imaging.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This FDA Class II device recall involves a software malfunction with no reported injuries or illnesses. The operational nature of the defect and absence of reported harm place this in the Moderate category per the rubric.
Plain-English summary
Shanghai United Imaging Healthcare Co., Ltd. is recalling one uEXPLORER PET/CT System (Model 88000025) due to an issue where the EXAM acquisition workflow could occasionally freeze after a user cancels a PET scan. The software freeze may interrupt diagnostic imaging operations.
The affected system has been distributed nationwide in California, Illinois, Indiana, Texas, and Wisconsin (Serial Number F00002). The uEXPLORER PET/CT System is designed for qualified healthcare professionals to assist in diagnosis and treatment planning for conditions in oncology, cardiology, and neurology. Healthcare facilities operating the affected system should contact the manufacturer for information on corrective measures.
The recalled product
- Product
- 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, on
- Manufacturer
- Shanghai United Imaging Healthcare Co., Ltd.
- Hazard
- software-freeze
- workflow-disruption
Distribution
Distributed nationwide across the United States.
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