United Imaging uCT 530 CT Systems Recalled for Software Visibility Issue
Shanghai United Imaging Healthcare is recalling four uCT 530 CT systems due to a software defect that may hide patient images, potentially requiring rescans.
What this means for you
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: The recall is classified as FDA Class II, and the hazard involves a risk of harm (need for rescans) without reported injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Shanghai United Imaging Healthcare Co., Ltd. is recalling four units of the Computed Tomography X-ray System, Model uCT 530, due to a software defect. The recall covers systems distributed nationwide in specific US states, including California, Texas, and New York.
The software issue occurs when the Split or Local function is enabled and multiple RIS exams are merged into a single study. This defect prevents patient images from being visible on the Patient Administration interface. As a result, healthcare facilities may need to perform rescans of patients to ensure images are properly captured and available.
Healthcare providers should contact Shanghai United Imaging Healthcare to resolve the software issue. The recall is classified as Class II by the FDA, indicating that the defect may cause temporary or medically reversible health consequences, such as the need for additional imaging procedures.
The recalled product
- Product
- Computed Tomography X-ray System, Model: uCT 530 with software
- Manufacturer
- Shanghai United Imaging Healthcare Co., Ltd.
- Affected units
- 4
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- 304006/R001.17.6.1607336-Re3100SP4
- 304007/R001.19.4.1810621-Re3300SP1H1_P3
- 304008/R001.19.4.1810621-Re3300SP1H1_P3
Distribution
Related recalls
Same manufacturer · Shanghai United Imaging Healthcare Co., Ltd.
See all →- ModerateUnited Imaging uCT 780 CT System Recalled for Software Visibility Issue
FDA (Devices) · 2026-10-07
- ModerateUnited Imaging uCT 550 CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
- ModerateUnited Imaging uMI Panorama 35 PET/CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
- ModerateUnited Imaging uMI 550 PET/CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
- ModerateUnited Imaging uMI Panorama GS PET/CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
Same hazard · software defect
See all →- ModeratePhilips Upgrade dStream Software Recall for Incorrect DTI Data Exports
FDA (Devices) · 2026-10-07
- ModeratePhilips MR 7700 MRI Systems Recalled for Incorrect DTI Data Exports
FDA (Devices) · 2026-10-07
- ModerateUnited Imaging uMI Panvivo S PET/CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
- ModeratePhilips Recalls Ingenia MRI Systems Due to Incorrect DTI Export Data
FDA (Devices) · 2026-10-07
- ModeratePhilips Recalls SmartPath MRI Software Due to Incorrect DTI Export Data
FDA (Devices) · 2026-10-07
Similar recalls
- ModerateUnited Imaging uCT 550 CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
- ModerateUnited Imaging uCT 780 CT System Recalled for Software Visibility Issue
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 uCT ATLAS CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
- HighUnited Imaging uCT 530 CT System Recalled for Scanning Interruptions
FDA (Devices) · 2020-07-08