Reported Aug 26, 2020 · Terminated
Positron Emission Tomography and Computed Tomography System, Model: uMI 550, Material Number: 88000057 - Product Usage:…
Shanghai United Imaging Healthcare Co., Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Shanghai United Imaging Healthcare Co., Ltd. · No. 2258 Chengbei Rd, Jiading Ind. · Shanghai, N/A · N/A
Is this the product you have?
- Positron Emission Tomography and Computed Tomography System
- ModeluMI 550
- Material Number88000057 -
- Product UsageThis 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
- Lot codes and dates
- UDI06971576832026
- Software VersionR001.3.0.0.750505
- Serial Numbers
200017200023200024
- Amount recalled
- 3
Where it was sold
- Nationwide
- TX
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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