| Class 2 Device Recall uEXPLORER PET/CT System | |
Date Initiated by Firm | August 02, 2021 |
Create Date | September 29, 2021 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-2594-2021 |
Recall Event ID |
88521 |
510(K)Number | K182237 K193241 |
Product Classification |
System, tomography, computed, emission - Product Code KPS
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Product | uEXPLORER PET/CT 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: 88000025
GTIN/UDI Code: 06971576832040 / 01 06971576832040 240 88000025 21 F00002
Serial Numbers:
F00002 |
Recalling Firm/ Manufacturer |
Shanghai United Imaging Healthcare Co., Ltd. No. 2258 Chengbei Rd, Jiading Ind. Shanghai China
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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 | 1 system |
Distribution | U.S. Nationwide distribution in the states of CA, IL, IN, TX, and WI.
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Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = KPS 510(K)s with Product Code = KPS
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