Recall record at a glance
| Official record | Z-2819-2020 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Shanghai United Imaging Healthcare Co., Ltd. |
| Report date | Aug 26, 2020 |
| Recall initiation date | Mar 26, 2020 |
| Quantity | 3 |
| Location | Shanghai, N/A, China |
Official product 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.
Why the product 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.
Distribution information
US Nationwide distribution including in the state of TX.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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