PET/CT Imaging System Recall: Software Issue Prevents Image Reconstruction
Shanghai United Imaging uMI 550 PET/CT imaging system is recalled due to a software defect that may prevent scatter correction during patient scanning, potentially blocking diagnostic PET image generation.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical imaging device recall. The source reports no illnesses or injuries; the hazard is a software defect that may prevent diagnostic image generation. Per the rubric, hazards without reported illness or injury are rated at most 3 (High). A diagnostic-critical medical imaging device warrants High rather than lower severity despite absence of reported patient harm.
Plain-English summary
Shanghai United Imaging Healthcare Co., Ltd. is recalling 47 units of its uMI 550 Positron Emission Tomography (PET) and Computed Tomography (CT) imaging system in the United States. The affected models are 88000657 and 88000057, with distribution reported in Texas.
The recall is due to a software issue occurring during patient scanning. The scatter correction process may occasionally fail, which would prevent the reconstruction and generation of diagnostic PET images.
This is an FDA Class II recall. Affected systems are medical imaging devices that may fail to produce PET diagnostic images due to the software defect.
The recalled product
- Product
- Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI 550 Part Number: 88000657 88000057
- Manufacturer
- Shanghai United Imaging Healthcare Co., Ltd.
- Affected units
- 47
Distribution
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