Z-3281-2026Class II

Shanghai United Imaging Healthcare Co., Ltd.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm

Product type

Device

Status

Ongoing

Report date

2026-10-07

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.

Product quantity

Initiated by

Voluntary: Firm initiated

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.

Product description

Computed Tomography X-ray System, Model: uCT ATLAS with software

Code / lot info

UDI-DI: 06971576831104. Serial Number/Software: 863001/R001.17.6.1607336-Re3100SP4, 863002/R001.17.6.1607336-Re3100SP4, 863004/R001.17.6.1607336-Re3100SP4, 863005/R001.17.6.1607336-Re3100SP4, 863007/R001.21.0.1897081-Re3310SP1, 863008/R001.21.0.1897081-Re3310SP1, 869001/R001.22.0.2012850-Re3320, 869002/R001.19.4.1810621-Re3300SP1H1_P3, 869003/R001.21.0.1897081-Re3310SP1, 869004/R001.21.0.1897081-Re3310SP1, 11CT863010/R001.17.6.1607336-Re3100SP4

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →