FDA Posts Class 2 Recalls of 11 United Imaging CT and PET/CT Scanner Models

The Food and Drug Administration has posted Class 2 recalls of 11 computed tomography (CT) and PET/CT scanner models made by Shanghai United Imaging Healthcare, over a software problem that can keep patient images from appearing on the systems' patient administration screen.

The entries in the FDA's medical device recall database, all posted on September 25, 2026 and numbered Z-3278-2026 through Z-3288-2026, describe the same issue. According to the entry for the uMI 550 PET/CT, the systems have a software problem when the Split or Local function is enabled and multiple radiology information system (RIS) exams are merged into a single study, which prevents patient images from being visible on the Patient Administration interface and may result in the need for rescans. The FDA lists the cause as software design.

Models and quantities

The recalls cover five CT models and six PET/CT models. On the CT side, the database lists 53 uCT ATLAS Astound systems, 23 uCT 550 systems, 14 uCT 780 systems, 11 uCT ATLAS systems and one uCT 760.

On the PET/CT side, it lists 34 uMI 550 systems, seven uMI Panorama 35, six uMI Panvivo S, three uMI Panorama GS, three uMI Panvivo and one uMI 780. In total, the listed quantities come to 156 systems. The entries describe U.S. nationwide distribution, listing states from California to New Jersey along with Puerto Rico.

The recalls were initiated by the firm on August 11 and remain open, according to the database. Each entry is marked as classified, and the FDA notes that not all products have yet been corrected.

What customers were told

On August 11, United Imaging emailed correction notices telling customers that software will be released to resolve the problem, the entries state. In the meantime, the company asked customers using the Study Split function to temporarily disable it by unchecking the Auto Study Split option in the system configuration interface.

If study splitting is clinically necessary, customers were told to select Split on PACS instead of Split on Local, and to make sure a picture archiving and communication system (PACS) is configured on site with auto-archive enabled. If images are missing from the patient administration screen, the notice asks staff to check whether the data exists in PACS and retrieve it from there, or to contact a United Imaging service engineer if it does not.

The recall database entries list 510(k) clearance numbers for each model. For the uMI 550, the FDA lists K182237 and K193241; for the uMI 780, K172143.

Per FDA policy, recall cause determinations in the database are subject to modification up to the point a recall is terminated, the agency notes on each entry.