GE Medical Systems Recalls CT and PET Scanners for Incorrect Torque Values
GE Medical Systems is recalling 104 CT and PET/CT scanners worldwide because service manuals contained incorrect torque values.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as Low severity because it involves a documentation error (incorrect torque value in service manuals) with no reported injuries or illnesses, fitting the criteria for documentation issues.
Plain-English summary
GE Medical Systems, LLC is recalling 104 units of various CT and PET/CT scanner systems, including the LightSpeed QX/I, LightSpeed 4.0, PET Discovery ST, LightSpeed Pro16, and Discovery XR/XA/LS systems. The recall is due to an error in the Service Manuals where an incorrect torque value was listed.
The affected devices are distributed worldwide, including in the United States (excluding North Dakota, Vermont, and Wyoming) and numerous foreign countries. The specific hazard is the potential for improper assembly or maintenance due to the incorrect torque specifications provided in the documentation.
Healthcare facilities should contact GE Medical Systems to obtain the updated Service Manuals. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- LightSpeed QX/I (4-slice MDAS) 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 attenuat
- Manufacturer
- GE Medical Systems, LLC
- Hazard
- Affected units
- 104
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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