FDAFDA · Food and drugs·Recall number Z-2819-2020
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.
Published August 26, 2020 · Recall initiated: March 26, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Shanghai United Imaging Healthcare Co., Ltd.
- Distributor
- US Nationwide distribution including in the state of TX.
- Lot
- UDI: 06971576832026, Software Version: R001.3.0.0.750505, Serial Numbers: 200017, 200023, 200024
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- China
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.