Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama 35 with software
Summary
The FDA issued a Class II for Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama by Shanghai United Imaging Healthcare Co., Ltd.. Reason: Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS e.
Details
Source
Device Recall
External ID
Z-3284-2026
Action Date
2026-10-07
Status
Ongoing
Category
device
Product Description
Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama 35 with software
Lot/Code Info: UDI-DI: 06971576832170. Serial Number: 11MI410003/R001.19.4.1909524, 11MI410004/R001.19.4.1909524, 11MI410005/R001.19.4.1909524, 20MI410001/R001.19.4.1909524, 20MI410002/R001.19.4.1909524, 20MI410003/R001.21.0.1993334, 20MI410004/R001.19.4.1909524
Quantity Affected: 7
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-11
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 238 device recalls issued in the same week, part of 518 device-related FDA actions this month.
Shanghai United Imaging Healthcare Co., Ltd. has 59 FDA actions in our database, including 15 recalls and 44 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Shanghai United Imaging Healthcare Co., Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Shanghai United Imaging Healthcare Co., Ltd. have FDA actions?
Shanghai United Imaging Healthcare Co., Ltd. has 59 FDA actions in our database, including 15 recalls and 44 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3284-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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