United Imaging uCT 760 CT Scanner Recalled for Timer Display Error
Shanghai United Imaging Healthcare is recalling five uCT 760 CT scanners because a display error may cause operators to receive unnecessary radiation exposure.
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 criteria for a High severity score.
Plain-English summary
Shanghai United Imaging Healthcare Co., Ltd. is recalling five units of the Computed Tomography X-Ray System, Model uCT 760. The recall is due to a potential issue where an incorrect CT scan delay timer may be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning.
This display error could lead the operator to receive unnecessary exposure to radiation. The affected units were distributed nationwide in the United States, including in the state of Texas. The specific serial numbers for the recalled units are 600229, 600230, 600232, 600271, and 600282.
Healthcare facilities should contact Shanghai United Imaging Healthcare Co., Ltd. for further instructions on how to address the issue with the affected equipment.
The recalled product
- Product
- Computed Tomography X-Ray System, Model uCT 760, Rx, CE, GTIN: 06971576831043 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body…
- Manufacturer
- Shanghai United Imaging Healthcare Co., Ltd.
- Hazard
- 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 (5)
- Serial Numbers: 600229
- 600230
- 600232
- 600271
- 600282
Distribution
Part of a larger recall action
This product is one of 4 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 4 products in this recall →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 · 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 760 CT System Recalled for Image Artifacts
FDA (Devices) · 2020-07-15
- HighUnited Imaging uCT 530 CT System Recalled for Scanning Interruptions
FDA (Devices) · 2020-07-08
- HighUnited Imaging uCT 760 CT Systems Recalled for Sharp Metal Edges
FDA (Devices) · 2020-08-05
- HighUnited Imaging uCT 550 CT System Recalled for Image Artifacts
FDA (Devices) · 2020-07-29
- 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