Positron Emission Tomography and Computed Tomography recall: Software Issue
Positron Emission Tomography and Computed Tomography System, Model: uMI 550, Material Number: 88000057 - Product Usage: This system is intended to be…
Why was Positron Emission Tomography and Computed Tomography 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI: 06971576832026, Software Version: R001.3.0.0.750505, Serial Numbers: 200017, 200023, 200024
- Product
- Positron Emission Tomography and Computed Tomography System, Model: uMI 550, Material Number: 88000057 - Product Usage: This system is intended to be…
- Recalling firm
- Shanghai United Imaging Healthcare Co., Ltd.
- Quantity
- 3
- Distribution
- US Nationwide distribution including in the state of TX.
- Recall date
- August 26, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)