GE Medical Systems Recalls CT and PET CT Scanners for Incorrect Torque Values
GE Medical Systems is recalling 324 CT and PET CT scanners worldwide because service manuals contained incorrect torque values.
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 2/5 (Moderate).
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, but the hazard involves an incorrect torque value in service manuals with no reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
GE Medical Systems, LLC is recalling 324 units of various CT and PET CT scanner systems, including the LightSpeed 16, LightSpeed 4.0, LightSpeed Pro16, and Discovery ST, XR, XA, and LS systems. The recall was initiated because the Service Manuals for these devices contained an incorrect torque value.
The affected devices were distributed worldwide, including in the United States (excluding North Dakota, Vermont, and Wyoming) and numerous foreign countries. The recall involves 324 specific units identified by their serial numbers and system IDs.
Healthcare facilities should contact GE Medical Systems to obtain the updated Service Manuals with the correct torque values. No injuries or illnesses have been reported in connection with this recall.
The recalled product
- Product
- LightSpeed 16 (MDAS only , , 2339985 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body…
- Manufacturer
- GE Medical Systems, LLC
- Hazard
- Affected units
- 324
Distribution
Part of a larger recall action
This product is one of 6 recalled by GE Medical Systems, LLC 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 6 products in this recall →Related recalls
Same manufacturer · GE Medical Systems, LLC
See all →- HighMobile Digital Radiographic System Arm Drop Risk During Patient Exams
FDA (Devices) · 2026-07-22
- HighGE Optima XR200/220/240amx Radiographic System Column Safety Mechanism
FDA (Devices) · 2026-07-22
- HighGE Medical Optima XR200/220/240amx Mobile Radiographic Systems Recall
FDA (Devices) · 2026-07-22
- HighGiraffe OmniBed incubator canopy fasteners can fall into patient compartment
FDA (Devices) · 2026-06-24
- HighGiraffe OmniBed replaceable units share the canopy fastener disengagement defect
FDA (Devices) · 2026-06-24
Similar recalls
- SevereGE Healthcare Recalls CT Scanners Due to Over-Torqued Bolts
FDA (Devices) · 2015-05-27
- HighGE Healthcare Recalls CT Scanners Due to Heat Exchanger Bolt Defect
FDA (Devices) · 2013-05-08
- HighGE Healthcare Recalls Lightspeed 16 CT Scanners Due to Power Supply Expulsion Risk
FDA (Devices) · 2015-09-30
- HighGE Healthcare Recalls PET Discovery ST 16 Scanners Due to Power Supply Risk
FDA (Devices) · 2015-09-30
- HighGE Revolution CT Recalled for Potential X-Ray Tube Loosening
FDA (Devices) · 2016-05-11
- HighGE Healthcare Recalls Three Revolution CT Systems for Protocoling Errors
FDA (Devices) · 2020-12-30