GE Healthcare Recalls Revolution CT Systems with SmartStep Option
GE Healthcare is recalling 131 Revolution CT systems with the SmartStep Option because the displayed Z location may not match the actual table position, potentially causing scans at incorrect locations.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (incorrect scan location) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
GE Healthcare, LLC is recalling 131 units of Revolution CT systems equipped with the SmartStep Option. These systems are intended for head, whole body, cardiac, and vascular X-ray Computed Tomography applications. The recall covers units distributed in the United States and internationally in Australia, Belgium, Canada, Estonia, Finland, France, Germany, Hong Kong, Ireland, Japan, Korea Republic of, Malaysia, Morocco, New Zealand, Norway, Saudi Arabia, Singapore, Slovakia, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, and the United Kingdom.
The recall is due to a defect where the Z location displayed on the image annotation and gantry display may not correspond to the actual location of the table. This discrepancy may result in the system scanning at a location that was not confirmed by the operator. The agency has classified this as a Class II recall.
Healthcare facilities using these systems should contact GE Healthcare for further instructions on how to address the issue. No specific instructions for end-users are provided in the source text, but the risk involves potential imaging errors due to incorrect table positioning.
The recalled product
- Product
- Revolution CT systems with the SmartStep Option The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
- Manufacturer
- GE Healthcare, LLC
- Affected units
- 131
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)
- SmartStep Option
Distribution
Distributed nationwide across the United States.
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