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.
What this means for you
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 att
- 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.
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