GE Medical Systems Recalls CT and PET CT Scanners for Service Manual Error
GE Medical Systems is recalling 25 CT and PET CT scanner systems because their service manuals contain an incorrect torque value.
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 issue (incorrect torque value in service manuals) rather than a direct physical hazard or reported injury.
Plain-English summary
GE Medical Systems, LLC is recalling 25 units of various CT and PET CT scanner systems, including the LightSpeed Ultra, LightSpeed 4.0, PET Discovery ST, LightSpeed Pro16, and Discovery XR/XA/LS systems. The recall was initiated because the Service Manuals for these devices were updated to correct an incorrect torque value.
The affected units were distributed worldwide, including in the United States (excluding North Dakota, Vermont, and Wyoming) and numerous foreign countries. The specific serial numbers and system IDs for the affected units are listed in the official recall documentation.
Healthcare facilities should contact GE Medical Systems to obtain the updated Service Manuals. This recall addresses a documentation error in the maintenance instructions rather than a defect in the physical hardware of the scanners.
The recalled product
- Product
- LightSpeed Ultra (8-slice MDAS), 5120327-3 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…
- Manufacturer
- GE Medical Systems, LLC
- Hazard
- Affected units
- 25
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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