PET/CT Imaging System Recall: Software Issue Prevents Image Reconstruction
Shanghai United Imaging uMI 550 PET/CT imaging system is recalled due to a software defect that may prevent scatter correction during patient scanning, potentially blocking diagnostic PET image generation.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical imaging device recall. The source reports no illnesses or injuries; the hazard is a software defect that may prevent diagnostic image generation. Per the rubric, hazards without reported illness or injury are rated at most 3 (High). A diagnostic-critical medical imaging device warrants High rather than lower severity despite absence of reported patient harm.
Plain-English summary
Shanghai United Imaging Healthcare Co., Ltd. is recalling 47 units of its uMI 550 Positron Emission Tomography (PET) and Computed Tomography (CT) imaging system in the United States. The affected models are 88000657 and 88000057, with distribution reported in Texas.
The recall is due to a software issue occurring during patient scanning. The scatter correction process may occasionally fail, which would prevent the reconstruction and generation of diagnostic PET images.
This is an FDA Class II recall. Affected systems are medical imaging devices that may fail to produce PET diagnostic images due to the software defect.
The recalled product
- Product
- Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI 550 Part Number: 88000657 88000057
- Manufacturer
- Shanghai United Imaging Healthcare Co., Ltd.
- Affected units
- 47
Distribution
Related recalls
Same manufacturer · Shanghai United Imaging Healthcare Co., Ltd.
See all →- ModerateUnited Imaging uMI Panorama GS 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 defect
See all →- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- HighPhilips Spectral CT Systems Recalled for Software Issues Affecting Safety
FDA (Devices) · 2026-10-14
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- ModerateUnited Imaging uCT 550 CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
- ModeratePhilips SmartPath to MR 7700 Recalled for Incorrect DTI Export Data
FDA (Devices) · 2026-10-07
Similar recalls
- ModerateUnited Imaging uMI 550 PET/CT System Recalled for Software Bugs
FDA (Devices) · 2020-04-22
- ModerateUnited Imaging uMI 550 PET/CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
- ModerateUnited Imaging uMI 780 PET/CT System Software Recall
FDA (Devices) · 2026-10-07
- ModerateUnited Imaging uMI Panorama GS PET/CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
- ModerateUnited Imaging uCT 550 CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
- ModerateUnited Imaging uMI 550 PET/CT Systems Recalled for Software Display Issue
FDA (Devices) · 2020-08-26