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U.S. Department of Health and Human Services

Class 2 Device Recall uCT 530

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  Class 2 Device Recall uCT 530 see related information
Date Initiated by Firm May 08, 2020
Create Date June 30, 2020
Recall Status1 Open3, Classified
Recall Number Z-2472-2020
Recall Event ID 85809
510(K)Number K181414  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product uCT 530 Computed Tomography X-Ray System
Code Information Units with software version no. R001.11.0.729741-Re-1100 including the following: Serial number/GTIN: 300162 (GTIN: 6971576831012); 300163 (GTIN: 6971576831012);  300174 (GTIN: 6971576831012); and 300176 (GTIN: 6971576831012).
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 a service function which may cause false marking of a bad channel resulting in ring artifacts, and potential intermittent scout scanning interruption due to occasional angle signal drift.. If these problems occur, it may be necessary to rescan the patient resulting in an additional dose of radiation and the possible need for additional contrast medium.
FDA Determined
Cause 2		 Software design
Action The firm sent letters to their customers by email on 5-22-2020. The letter informs customers of the two potential safety issues with the device, and notes that these problems may cause image artifacts and scanning workflow interruptions. Risks to patient health are noted to include the possible need to rescan the patient resulting in an additional radiation dose and the possible need for additional contrast medium. Customers were informed that United Imaging has released a field update for the uCT 530 to address the issues. If customers observe image artifacts, they are requested to reboot the system and continue the reconstruction. If the scout scanning is interrupted, customers are instructed to try repeating the scout scanning. If problems persist, customers should 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).
Quantity in Commerce 4 units
Distribution Distributed to 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 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 = JAK and Original Applicant = Shanghai United Imaging Healthcare Co., Ltd.
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