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U.S. Department of Health and Human Services

Class 2 Device Recall uMI 550 System

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  Class 2 Device Recall uMI 550 System see related information
Date Initiated by Firm August 02, 2021
Create Date September 29, 2021
Recall Status1 Open3, Classified
Recall Number Z-2593-2021
Recall Event ID 88521
510(K)Number K182237  K193241  
Product Classification System, tomography, computed, emission - Product Code KPS
Product uMI 550 System - Product Usage: 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 Model: 88000057 GTIN/UDI Codes: 06971576832026 / 01 06971576832026 240 88000057 21 200017 06971576832026 / 01 06971576832026 240 88000057 21 200023 06971576832026 / 01 06971576832026 240 88000057 21 200024 06971576832026 / 01 06971576832026 240 88000057 21 200036 06971576832026 / 01 06971576832026 240 88000057 21 200045 06971576832026 / 01 06971576832026 240 88000057 21 200047 06971576832057 / 01 06971576832057 240 88000057 21 230002 06971576832057 / 01 06971576832057 240 88000057 21 230003 06971576832057 / 01 06971576832057 240 88000057 21 230004 06971576832057 / 01 06971576832057 240 88000057 21 200059 06971576832057 / 01 06971576832057 240 88000057 21 230005 06971576832057 / 01 06971576832057 240 88000057 21 230006 06971576832057 / 01 06971576832057 240 88000057 21 230007 06971576832057 / 01 06971576832057 240 88000057 21 230008 06971576832057 / 01 06971576832057 240 88000057 21 230009 06971576832057 / 01 06971576832057 240 88000057 21 230010 06971576832057 / 01 06971576832057 240 88000057 21 230011 06971576832057 / 01 06971576832057 240 88000057 21 230012 06971576832057 / 01 06971576832057 240 88000057 21 230013 06971576832057 / 01 06971576832057 240 88000057 21 230014 06971576832057 / 01 06971576832057 240 88000057 21 230015 06971576832057 / 01 06971576832057 240 88000057 21 230016 06971576832057 / 01 06971576832057 240 88000057 21 230017 Serial Numbers: 200017; 200023; 200024; 200036; 200045; 200047; 230002; 230003; 230004; 200059; 230005; 230006; 230007; 230008; 230009; 230010; 230011; 230012; 230013; 230014; 230015; 230016; 230017;
Recalling Firm/
Manufacturer		 Shanghai United Imaging Healthcare Co., Ltd.
No. 2258 Chengbei Rd, Jiading Ind.
Shanghai China
Manufacturer Reason
for Recall		 The EXAM acquisition workflow could occasionally freeze after canceling the PET scan.
FDA Determined
Cause 2		 Device Design
Action On 08/02/2021, the Firm emailed to its customer an "Advisory Notification" informing them of a potential safety-relevant issue in which the EXAM acquisition workflow could occasionally freeze after canceling the PET scan. The issue and the sequence of events leading to this occurrence are as follow: During a myocardial perfusion scan procedure, the follow steps could lead to the EXAM acquisition workflow to occasionally freeze- 1. Selecting the myocardial perfusion scan procedure and entering EXAM. 2. Finishing the CT scout and helical/cine scan. 3. Starting the PET scan. 4. Canceling the current PET scan -- in this case the EXAM acquisition workflow may shut down, resulting in an error message stating: "EXAM (Study ID: XXXXXXX) has some errors, trying to restart. Please wait and try again. 5. Reentering the EXAM acquisition workflow without restarting the system, and then attempting to continue the scan. If the above occurs, this may require rescanning of the patient, resulting in additional CT dose exposure. Customer are instructed to: 1. When the EXAM acquisition workflow is interrupted after cancellation of the scan, follow the steps to resume the procedure: a) Wait until CT reconstruction finishes. b) Perform a system restart. c) After restart, select the suspended procedure on the patient administration (PA) interface and enter EXAM. System will load and recover the status of this procedure. d) Duplicate or copy and paste the unfinished PET scan, and then continue. 2. Please notify all internal users of the PET/CT system, using this letter. 3. Complete and sign the Receipt of Advisory Notification Form and return it to the Recalling Firm via fax, email or mail. The Recalling Firm is working on releasing a software update to resolve this issue. Planned release of software update is Q4 of 2021. For questions, contact the Recalling Firm's service engineer or call the customer contact center's 24 hour hotline at (855)221-1552 (toll free) or (832)699-2799 (d
Quantity in Commerce 23 systems
Distribution U.S. Nationwide distribution in the states of CA, IL, IN, TX, and WI.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = KPS and Original Applicant = Shanghai United Imaging Healthcare Co., Ltd
510(K)s with Product Code = KPS and Original Applicant = Shanghai United Imaging Healthcare Co., Ltd.
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