United Imaging uCT ATLAS CT Systems Recalled for Software Defect
Shanghai United Imaging Healthcare is recalling 11 uCT ATLAS CT systems due to a software issue that may hide patient images, potentially requiring rescans.
What this means for you
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: The recall is classified as FDA Class II. The source text describes a software defect that may result in the need for rescans but does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
Shanghai United Imaging Healthcare Co., Ltd. is recalling 11 Computed Tomography (CT) X-ray Systems, Model uCT ATLAS, due to a software defect. The recall affects units distributed in 30 U.S. states and Puerto Rico.
The software issue occurs when the Split or Local function is enabled and multiple RIS exams are merged into a single study. This prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.
Affected serial numbers and software versions are listed in the agency's recall record. Healthcare facilities should contact the manufacturer for instructions on resolving the software issue.
The recalled product
- Product
- Computed Tomography X-ray System, Model: uCT ATLAS with software
- Manufacturer
- Shanghai United Imaging Healthcare Co., Ltd.
- Affected units
- 11
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 (10)
- 863002/R001.17.6.1607336-Re3100SP4
- 863004/R001.17.6.1607336-Re3100SP4
- 863005/R001.17.6.1607336-Re3100SP4
- 863007/R001.21.0.1897081-Re3310SP1
- 863008/R001.21.0.1897081-Re3310SP1
- 869001/R001.22.0.2012850-Re3320
- 869002/R001.19.4.1810621-Re3300SP1H1_P3
- 869003/R001.21.0.1897081-Re3310SP1
- 869004/R001.21.0.1897081-Re3310SP1
- 11CT863010/R001.17.6.1607336-Re3100SP4
Distribution
Related recalls
Same manufacturer · Shanghai United Imaging Healthcare Co., Ltd.
See all →- 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
- HighUnited Imaging uCT 530 CT Systems 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 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 CT System Recall Due to Software Image Visibility Issue
FDA (Devices) · 2026-10-07
- 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
- HighUnited Imaging uCT 530 CT Systems Recalled for Software Visibility Issue
FDA (Devices) · 2026-10-07
- ModerateUnited Imaging uCT 760 CT System Recalled for Software Visibility Issue
FDA (Devices) · 2026-10-07
- HighUnited Imaging uCT 530 CT System Recalled for Scanning Interruptions
FDA (Devices) · 2020-07-08