United Imaging uMI 550 PET/CT System Recalled for Software Bugs
Shanghai United Imaging Healthcare is recalling two uMI 550 PET/CT systems due to software bugs that may cause reconstruction problems and patient rescans.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, and the hazard involves potential additional radiation dose from rescans without reported injuries, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Shanghai United Imaging Healthcare Co., Ltd. is recalling two units of the Positron Emission Tomography and Computed Tomography (PET/CT) System, Model uMI 550. The affected units are equipped with software version R001.3.0.0.750505 and have serial numbers 200017 and 200023. These systems are intended for use by qualified healthcare professionals to assist in the detection, localization, diagnosis, and treatment planning for diseases in oncology, cardiology, and neurology.
The recall is due to potential sporadic software bugs in the specified version. These bugs may cause issues with PET acquisition raw data, leading to reconstruction problems during PET/CT scanning. As a result, patients may require rescans, which could expose them to additional radiation dose.
The affected units were distributed in Texas. Healthcare facilities and users of these specific serial numbers should contact the recalling firm for further instructions on how to address the software issue.
The recalled product
- Product
- Positron Emission Tomograpy and Computed Tomography System, Model: uMI 550, with software version R001.3.0.0.750505, Rx Only, CE 0197, UDI: (01)06971576832026 - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the…
- Manufacturer
- Shanghai United Imaging Healthcare Co., Ltd.
- Affected units
- 2
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 (1)
- Serial Numbers: 200017 and 200023
Distribution
Distributed nationwide across the United States.
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