GE Medical Systems Recalls CT and PET CT Scanners for Manual Error
GE Medical Systems is recalling specific CT and PET CT scanners because service manuals contained 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 manuals) with no reported injuries or illnesses, fitting the rubric for packaging or documentation-only problems.
Plain-English summary
GE Medical Systems, LLC is recalling specific CT and PET CT scanner systems, including the LightSpeed Plus, LightSpeed 4.0, PET Discovery ST, LightSpeed Pro16, Discovery XR, Discovery XA, and Discovery LS models. The recall is due to an error in the Service Manuals for these devices, which listed an incorrect torque value.
The affected units were distributed worldwide, including the United States (excluding North Dakota, Vermont, and Wyoming) and numerous foreign countries. The recall is limited to the documentation provided with the devices.
Healthcare facilities should contact GE Medical Systems to obtain the corrected Service Manuals. No injuries or illnesses have been reported in connection with this recall.
The recalled product
- Product
- LightSpeed Plus (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
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Mfg Lot or Serial # System ID 00000002493PT5 0850450029
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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