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U.S. Department of Health and Human Services

Class 2 Device Recall Positron Emission Tomography and Computed Tomography System

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  Class 2 Device Recall Positron Emission Tomography and Computed Tomography System see related information
Date Initiated by Firm March 26, 2020
Create Date August 18, 2020
Recall Status1 Terminated 3 on August 02, 2023
Recall Number Z-2819-2020
Recall Event ID 85453
510(K)Number K182237  
Product Classification System, tomography, computed, emission - Product Code KPS
Product 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.
Code Information UDI: 06971576832026, Software Version: R001.3.0.0.750505, Serial Numbers: 200017, 200023, 200024 
Recalling Firm/
Manufacturer		 Shanghai United Imaging Healthcare Co., Ltd.
No. 2258 Chengbei Rd, Jiading Ind.
Shanghai China
For Additional Information Contact United Imaging Customer Contact Center
855-2211552
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Software design
Action On March 26, 2020, Customer Notification Letters were emailed to customers. The recalling firm has released a software hotfix to address the issue for the affected products. The corrective action of on-site upgrade will be provided free of charge. For further questions, feel free to contact the Customer Contact Center at (855) 221-1552 (toll free) or (832) 699-2799 (direct).
Quantity in Commerce 3
Distribution US Nationwide distribution including in the state of TX.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KPS and Original Applicant = Shanghai United Imaging Healthcare Co., Ltd.
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