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U.S. Department of Health and Human Services

Class 2 Device Recall uCT 760 Xray System

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  Class 2 Device Recall uCT 760 Xray System see related information
Date Initiated by Firm May 08, 2020
Create Date July 10, 2020
Recall Status1 Terminated 3 on January 20, 2022
Recall Number Z-2522-2020
Recall Event ID 85804
510(K)Number K172135  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product uCT 760 System, Computed Tomography X-ray System
Code Information Model uCT 760; Serial Numbers: 600229, 600230, 600232, 600271 with software version R001.11.0.729741-Re-1100, and serial number 600282 with software version R001.11.0.785930-Re-1150.
Recalling Firm/
Manufacturer		 Shanghai United Imaging Healthcare Co., Ltd.
No. 2258 Chengbei Rd, Jiading Ind.
Shanghai China
Manufacturer Reason
for Recall		 Two issues were identified with the computed tomography x-ray system including an intermittent issue which may affect image data leading to artifacts; and intermittent scout scanning interruption due to occasional angle signal drift. This may result in the need for rescanning of the patient with the patient receiving an additional dose of radiation and possible use of additional contrast media.
FDA Determined
Cause 2		 Software design
Action Customers were sent emails on 05/22/2020 notifying them of the failure modes and the potential safety issues. Customers were informed that If image artifacts occur, it may be necessary for the user to repeat the examination. The rescan of the patient will result in an additional dose and the possible need for additional contrast medium. Customers were also informed that if the scout scanning is unexpectedly interrupted, it may be necessary for the user to repeat the scout scanning, resulting in an additional dose. Customers observing image artifacts were instructed to reboot the system and continue the reconstruction, and, if image artifacts persist, to contact their United Imaging service support team or call the United Imaging Customer Contact Center at (855) 221-1552 (toll free) or (832) 699-2799 (direct). Similarly, if scout scanning is interrupted, customers were instructed to attempt repeating the scout and to contact the service support team if the problem continues. The email informs customers that United Imaging has released updated software R001.11.0.820958-Re-1150SP1+H1H2 to solve the intermittent issue and to eliminate angulation signal drift, which could eliminate the resulting image artifacts and scout scanning interruption, and to accomplish other improvements. Customers with further questions should contact the United Imaging Customer Contact Center at {855) 221-1552 {toll free) or {832) 699-2799 {direct).
Quantity in Commerce 5 units
Distribution Distributed to two customers. Both customers located in Houston, 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 = JAK and Original Applicant = Shanghai United Imaging Healthcare Co., Ltd.
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