GE Medical Systems Recalls CT and PET CT Scanners for Incorrect Torque Values
GE Medical Systems is recalling 522 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 source text describes a documentation error (incorrect torque value in service manuals) with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall or minor labeling/documentation error.
Plain-English summary
GE Medical Systems, LLC is recalling 522 units of various CT and PET CT scanner systems, including the Discovery ST, LightSpeed 4.0, LightSpeed Pro16, Discovery XR, Discovery XA, and Discovery LS models. The recall is due to an error in the Service Manuals, which listed an incorrect torque value for these devices.
The affected units were distributed worldwide, including in the United States (excluding North Dakota, Vermont, and Wyoming) and numerous foreign countries. The recall is limited to the documentation error; the source text does not report any injuries, illnesses, or device malfunctions resulting from the incorrect torque value.
Healthcare facilities should contact GE Medical Systems to obtain the updated Service Manuals. The recall is classified as FDA Class II, indicating that the defect could cause temporary or medically reversible health consequences, or that the probability of serious adverse health consequences is remote.
The recalled product
- Product
- Discovery ST, , 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 attenuation…
- Manufacturer
- GE Medical Systems, LLC
- Hazard
- Affected units
- 522
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.
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