uEXPLORER PET/CT System Workflow Freeze Recall
The uEXPLORER PET/CT System is being recalled because the EXAM acquisition workflow may freeze after canceling a PET scan. Affected systems may experience workflow interruptions during diagnostic imaging.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This FDA Class II device recall involves a software malfunction with no reported injuries or illnesses. The operational nature of the defect and absence of reported harm place this in the Moderate category per the rubric.
Plain-English summary
Shanghai United Imaging Healthcare Co., Ltd. is recalling one uEXPLORER PET/CT System (Model 88000025) due to an issue where the EXAM acquisition workflow could occasionally freeze after a user cancels a PET scan. The software freeze may interrupt diagnostic imaging operations.
The affected system has been distributed nationwide in California, Illinois, Indiana, Texas, and Wisconsin (Serial Number F00002). The uEXPLORER PET/CT System is designed for qualified healthcare professionals to assist in diagnosis and treatment planning for conditions in oncology, cardiology, and neurology. Healthcare facilities operating the affected system should contact the manufacturer for information on corrective measures.
The recalled product
- Product
- uEXPLORER PET/CT System - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to…
- Manufacturer
- Shanghai United Imaging Healthcare Co., Ltd.
- Affected units
- 1
Distribution
Part of a larger recall action
This product is one of 2 recalled by Shanghai United Imaging Healthcare Co., Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Shanghai United Imaging Healthcare Co., Ltd.
See all →- ModerateUnited Imaging uMI Panorama 35 PET/CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
- ModerateUnited Imaging CT System Recall Due to Software Image Visibility Issue
FDA (Devices) · 2026-10-07
- ModerateUnited Imaging uCT 760 CT System Recalled for Software Visibility Issue
FDA (Devices) · 2026-10-07
- ModerateUnited Imaging uMI 550 PET/CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
- ModerateUnited Imaging uMI Panvivo S PET/CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
Same hazard · software freeze
See all →- ModerateRadiometer ABL90 Series Blood Analyzers May Unexpectedly Freeze
FDA (Devices) · 2025-04-30
- SevereTANDEM LIFE controller software failures affecting cardiopulmonary bypass equipment nationwide
FDA (Devices) · 2022-10-05
- ModerateuMI 550 PET Imaging System Software Workflow May Occasionally Freeze
FDA (Devices) · 2021-10-06
- HighMindray BeneVision Distributed Monitoring System Recalled for Intermittent Freezes
FDA (Devices) · 2021-03-24
- ModeratePhilips BrightView Nuclear Imaging Systems Recalled for Motion and Software Issues
FDA (Devices) · 2017-03-22
Similar recalls
- HighUnited Imaging Recalls uEXPLORER PET/CT System for Potential Sharp Edges
FDA (Devices) · 2020-08-19
- HighUnited Imaging uCT 760 CT System Recalled for Image Artifacts
FDA (Devices) · 2020-07-15
- HighUnited Imaging uMI 550 PET/CT System Recalled for Incorrect CT Scan Delay Timer
FDA (Devices) · 2020-11-18
- HighUnited Imaging uCT 530 CT System Recalled for Scanning Interruptions
FDA (Devices) · 2020-07-08
- ModerateUnited Imaging uMI 550 PET/CT System Recalled for Software Bugs
FDA (Devices) · 2020-04-22
- HighPET/CT Imaging System Recall: Software Issue Prevents Image Reconstruction
FDA (Devices) · 2023-04-19