United Imaging uMI 550 PET/CT Systems Recalled for Software Display Issue
Shanghai United Imaging Healthcare Co., Ltd. is recalling three uMI 550 PET/CT systems because a software defect may prevent the CT Hounsfield unit curve from displaying in real time during specific scans.
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: The recall is classified as FDA Class II. The hazard involves a software display issue that may affect image enhancement and require patient rescans, but the source text does not report any injuries, illnesses, or deaths.
Plain-English summary
Shanghai United Imaging Healthcare Co., Ltd. is recalling three Positron Emission Tomography and Computed Tomography (PET/CT) Systems, Model uMI 550, Material Number 88000057. The affected units are identified by UDI 06971576832026, Software Version R001.3.0.0.750505, and serial numbers 200017, 200023, and 200024. These systems were distributed nationwide in the United States, including in Texas.
The recall is due to a software defect where the CT Hounsfield unit curve may not display in real time when using the bolus tracking protocol with the tracker scan function. If this occurs, subsequent clinical scanning protocols must be started manually. This issue may affect image enhancement and may result in the need for patient rescans.
The systems are 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 oncology, cardiology, and neurology. Healthcare facilities should contact the recalling firm for instructions on software updates or repairs.
The recalled product
- Product
- Positron Emission Tomography and Computed Tomography System, Model: uMI 550, Material Number: 88000057 - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment
- Manufacturer
- Shanghai United Imaging Healthcare Co., Ltd.
- Affected units
- 3
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- UDI: 06971576832026
- Software Version: R001.3.0.0.750505
- Serial Numbers: 200017
- 200023
- 200024
Distribution
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