FDAFDA recall Z-3288-2026 · Oct 7, 2026
Shanghai United Imaging Healthcare Co., Ltd.: Positron Emission Tomography and Computed Tomography System recall
Recall found
Product
Positron Emission Tomography and Computed Tomography System, Model: uMI 780
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.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- UDI-DI: 06971576832033. Serial Number/Software: 300098/R001. 19.0.1812568
- Quantity
- 1
- 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.
- Recalling firm
- Shanghai United Imaging Healthcare Co., Ltd., Shanghai
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-08-11
Source: openFDA enforcement record Z-3288-2026 · search recall number Z-3288-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.