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 planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.
Enforcement
- Recall Number
- Z-2819-2020
- Event ID
- 85453
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Shanghai United Imaging Healthcare Co., Ltd.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 26, 2020
- Initiation Date
- March 26, 2020
- Classification Date
- August 18, 2020
- Termination Date
- August 2, 2023
- Address
- No. 2258 Chengbei Rd, Jiading Ind., N/A, Shanghai, N/A, N/A, China
Description
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 planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.
In affected software version, of Positron emission tomography and computed tomography system, 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, the subsequent clinical scanning protocols will need to be started manually, which may effect image enhancement, and may result in patient rescan.
UDI: 06971576832026, Software Version: R001.3.0.0.750505, Serial Numbers: 200017, 200023, 200024
US Nationwide distribution including in the state of TX.
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