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.
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 1/5 (Low).
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…
- 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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