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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 530see related information
Date Initiated by FirmAugust 11, 2026
Date PostedSeptember 25, 2026
Recall Status1 Open3, Classified
Recall NumberZ-3277-2026
Recall Event ID 99731
510(K)NumberK181414 K200016 
Product Classification System, x-ray, tomography, computed - Product Code JAK
ProductComputed Tomography X-ray System, Model: uCT 530 with software
Code Information UDI-DI: 06971576831012. Serial Numbers/Software: 300174/R001.19.5.1839204-Re3300SP1H1_P4, 304006/R001.17.6.1607336-Re3100SP4, 304007/R001.19.4.1810621-Re3300SP1H1_P3, 304008/R001.19.4.1810621-Re3300SP1H1_P3
FEI Number 3011015597
Recalling Firm/
Manufacturer		 Shanghai United Imaging Healthcare Co., Ltd.
No. 2258 Chengbei Rd, Jiading Ind.
Shanghai China
Manufacturer Reason
for Recall		Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.
FDA Determined
Cause 2		Software design
ActionOn 8/11/2026, correction notices were emailed to customers informing them that software will be released to resolve the software problem. Customers were asked to do the following: When using the Study Split function, follow the requirements below: 1) Temporarily disable the "Study Split" function. Navigate to the system configuration interface and uncheck the "Auto Study Split" option. 2) If the "Study Split" function is clinically necessary, open the system configuration interface and select "Split on PACS" instead of "Split on Local". 3) When "Auto study split" is checked, ensure that PACS (Picture Archiving and Communication System) is configured on site and auto-archive is enabled. 4) If images are found to be missing on the PA interface, immediately verify whether the corresponding image data exists in the PACS. a) If images exist in PACS: They can be retrieved from PACS for review. b) If images do not exist in PACS: Contact the firm's service engineer for assistance. For further questions, contact firm service engineer or call firm Customer Contact Center at (855) 221-1552 or 832-699-2799
Quantity in Commerce4
DistributionUS Nationwide distribution in the states of CA, PR, UT, WV, ND, NE, NC, TX, ID, LA, MT, FL, CO, IN, KY, AL, OH, MI, IA, MO, NY, NV, TN, WV, SC, WI, IL, MS, MA, NJ.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JAK
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