GE Healthcare Recalls CT Scanners Due to Over-Torqued Bolts
GE Healthcare is recalling four CT scanners because over-torqued bolts could cause a component to detach, posing a risk of serious bodily injury.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as Severe because the source text explicitly states that the defect could result in serious bodily injury if the component is expelled, which aligns with the rubric criteria for significant injury reports or high-risk structural defects.
Plain-English summary
GE Healthcare is recalling four units of the CT LightSpeed 16 and Discovery ST Pet/CT DST scanners (Catalogue # 2339985). The recall was initiated because three bolts that secure a power supply to the rotating side of the gantry were found to be over-torqued on certain units.
The affected devices were distributed to the states of Minnesota, Florida, and Texas. The specific units are identified by the following System IDs: 00000331100CN8, 00000345975CN7, 00000337343CN8, and 00000344962CN6.
In the unlikely event that the component becomes loose on the CT gantry during operation, it could be expelled, resulting in serious bodily injury. No incidents or injuries have been reported as a result of this defect. Healthcare facilities should contact GE Healthcare to arrange for the necessary corrective actions.
The recalled product
- Product
- CT LightSpeed 16 and Discovery ST Pet/CT DST. Catalogue # 2339985. Designed to be a head and whole body CT scanner utilizing a new solid state detector.
- Manufacturer
- GE Healthcare
- Category
- Medical Device — CT Scanner
- Affected units
- 4
Distribution
Related recalls
Same manufacturer · GE Healthcare
See all →- HighGE Healthcare Recalls Centricity Enterprise Archive Software Due to Data Association Errors
FDA (Devices) · 2026-09-23
- HighGE Healthcare Recalls Centricity PACS Server V7 Due to Data Association Error
FDA (Devices) · 2026-09-23
- HighGE Healthcare Recalls Centricity PACS Software Due to Data Association Errors
FDA (Devices) · 2026-09-23
- HighGE Healthcare Recalls Core Services Hub V8 Due to Data Association Errors
FDA (Devices) · 2026-09-23
- HighGE Healthcare Recalls Workflow Core Services V8 Due to Data Association Errors
FDA (Devices) · 2026-09-23
Same hazard · mechanical failure
See all →- ModerateMedline Recalls Surgical Convenience Kits with Non-Conforming Cannula Components
FDA (Devices) · 2026-10-21
- HighMedline surgical kits recalled for non-conforming cannula components
FDA (Devices) · 2026-10-21
- ModerateMedline Recalls Surgical Kits With Non-Conforming Cannula Components
FDA (Devices) · 2026-10-21
- ModerateMedline Recalls Surgical Convenience Kits with Non-Conforming Cannula Components
FDA (Devices) · 2026-10-21
- HighBaxter Recalls Likorall Overhead Lifts Due to Motor Shaft Breakage Risk
FDA (Devices) · 2026-10-21
Similar recalls
- ModerateGE Medical Systems Recalls CT and PET CT Scanners for Incorrect Torque Values
FDA (Devices) · 2016-03-16
- HighGE Healthcare Recalls CT Scanners Due to Heat Exchanger Bolt Defect
FDA (Devices) · 2013-05-08
- LowGE Medical Systems Recalls CT and PET Scanners for Incorrect Torque Values
FDA (Devices) · 2016-03-16
- LowGE Medical Systems Recalls CT and PET CT Scanners for Service Manual Error
FDA (Devices) · 2016-03-16
- LowGE Medical Systems Recalls CT and PET CT Scanners for Manual Error
FDA (Devices) · 2016-03-16
- HighGE Healthcare Recalls PET Discovery ST 16 Scanners Due to Power Supply Risk
FDA (Devices) · 2015-09-30