Computed Tomography X-ray System (Z-3277-2026) Recall: Software Issue
Computed Tomography X-ray System, Model: uCT 530 with software
What is the FDA recall status?
The FDA record lists this recall as ongoing. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions and check the agency notice or firm for current guidance.
Why was Computed Tomography X-ray System recalled?
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.
What should I do if I have this product?
Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.
Which lot codes, UPCs or models are affected?
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
- Agency record number
- Z-3277-2026
- Product
- Computed Tomography X-ray System, Model: uCT 530 with software
- Recalling firm
- Shanghai United Imaging Healthcare Co., Ltd.
- Quantity
- 4
- Distribution
- US 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.
- Recall started
- August 11, 2026
- Report date
- October 7, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)