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U.S. Department of Health and Human Services

Class 2 Device Recall uEXPLORER

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  Class 2 Device Recall uEXPLORER see related information
Date Initiated by Firm July 16, 2020
Date Posted August 13, 2020
Recall Status1 Terminated 3 on July 07, 2022
Recall Number Z-2799-2020
Recall Event ID 85948
510(K)Number K182938  
Product Classification System, tomography, computed, emission - Product Code KPS
Product uEXPLORER PET/CT Diagnostic Imaging System - 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 Serial No. F00002; GTIN 06971576832040
Recalling Firm/
Shanghai United Imaging Healthcare Co., Ltd.
No. 2258 Chengbei Rd, Jiading Ind.
Shanghai China
Manufacturer Reason
for Recall
1) 1) Potential intermittent issue may cause image data problems, may lead to artifacts; 2) Potential intermittent scout scanning interruption due to angle signal drift caused by external interference; 3) Metal edge overlap of mylar strip in gantry may create sharp edge. May lead to repeat scanning and abrasions.
FDA Determined
Cause 2
Device Design
Action Urgent Medical Device Correction Letters regarding the uEXPLORER and uMI 550 were sent to customers on July 16, 2020 via email. Customers were informed that the firm had received complaints on these products and advised customers to take the following actions if problems were observed: 1. if image artifacts occur, reboot the system and continue the reconstruction. If necessary, repeat the scan which will result in an additional dose of radiation and the possible need for additional contrast medium. 2. If scout scanning is unexpectedly interrupted, try repeating the scout. This will result in an additional dose of radiation. 3: Be careful to avoid the sharp edge when the patient raises their arms during movement of the Ml patient table. Customers with questions may contact their United Imaging Service Engineer or call the United Imaging Customer Contact Center at 24-hour hotline (855) 221-1552 (toll free) or (832) 699-2799 (direct). Customers were advised to report adverse reactions or quality problems experienced with the use of these products to the FDA's MedWatch Adverse Event Reporting program either online, by regulatory mail or by fax. Customers were requested to in-turn notify all users of the affected products via the Customer Notification Letter. Customers were informed that United Imaging is updating software to solve these issues, and that United Imaging will replace the mylar strip with an improved one on the affected products via on-site update. Customers are requested to sign the Receipt of Customer Notification Form indicating they received the notice and that they will extend the notification to the final customer. Signed forms are to be returned to the recalling firm.
Quantity in Commerce 1 unit distributed to Texas
Distribution US Nationwide distribution including in the state of Texas.
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.