United Imaging uCT 760 CT System Recalled for Image Artifacts
Shanghai United Imaging Healthcare is recalling five uCT 760 CT systems due to intermittent image artifacts and scanning interruptions that may require patient rescans.
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: The recall involves a risk-of-harm product (radiation exposure) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Shanghai United Imaging Healthcare Co., Ltd. is recalling five units of the uCT 760 System, a computed tomography x-ray system. The recall affects specific serial numbers (600229, 600230, 600232, 600271, and 600282) running specific software versions. The devices were distributed to two customers located in Houston, Texas.
The recall was initiated because two issues were identified with the system: an intermittent issue that may affect image data leading to artifacts, and intermittent scout scanning interruption caused by occasional angle signal drift. These technical failures may result in the need to rescan patients, which could expose them to an additional dose of radiation and the possible use of additional contrast media.
The source text does not specify instructions for consumers or healthcare providers on how to proceed with the recall, nor does it report any injuries or illnesses associated with the device malfunction.
The recalled product
- Product
- uCT 760 System, Computed Tomography X-ray System
- Manufacturer
- Shanghai United Imaging Healthcare Co., Ltd.
- Affected units
- 5
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 (6)
- Model uCT 760
- Serial Numbers: 600229
- 600230
- 600232
- 600271 with software version R001.11.0.729741-Re-1100
- and serial number 600282 with software version R001.11.0.785930-Re-1150.
Distribution
Distributed in 1 state:
Related recalls
Same manufacturer · Shanghai United Imaging Healthcare Co., Ltd.
See all →- ModerateUnited Imaging uCT ATLAS 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
- 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
Same hazard · radiation exposure
See all →- HighPhilips Spectral CT 7500 Software Recall for Radiation Exposure Risk
FDA (Devices) · 2026-10-07
- HighPhilips Recalls IQon Spectral CT Systems Due to Radiation Issue
FDA (Devices) · 2026-09-09
- HighPhilips Brilliance CT Systems Recalled for Unintended Radiation Issue
FDA (Devices) · 2026-09-09
- HighPhilips CT Systems Recalled for Unintended Radiation Performance Issues
FDA (Devices) · 2026-09-09
- HighPhilips CT Systems Recalled for Unintended Radiation Performance Issues
FDA (Devices) · 2026-09-09
Similar recalls
- HighUnited Imaging uCT 550 CT System Recalled for Image Artifacts
FDA (Devices) · 2020-07-29
- HighUnited Imaging uCT 530 CT System Recalled for Scanning Interruptions
FDA (Devices) · 2020-07-08
- HighUnited Imaging uCT 760 CT Scanner Recalled for Timer Display Error
FDA (Devices) · 2020-11-18
- ModerateUnited Imaging uCT 760 CT System Recalled for Software Visibility Issue
FDA (Devices) · 2026-10-07
- ModerateUnited Imaging uCT 780 CT System Recalled for Software Visibility Issue
FDA (Devices) · 2026-10-07
- HighUnited Imaging uCT 760 CT Systems Recalled for Sharp Metal Edges
FDA (Devices) · 2020-08-05