GE Revolution CT Recalled for Potential X-Ray Tube Loosening
GE Medical Systems is recalling 26 Revolution CT systems worldwide because a manufacturing error may cause the X-ray tube to loosen, leading to scan errors or image artifacts.
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 3/5 (High).
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 involves a risk-of-harm product (medical device) where the defect could lead to scan aborts or image artifacts, but no injuries or illnesses have been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
GE Medical Systems, LLC is recalling 26 units of the GE Revolution CT system. These systems are intended for head, whole body, cardiac, and vascular X-ray Computed Tomography applications. The recall affects four units in the United States and 22 units distributed internationally to Australia, Canada, China, France, Germany, Italy, Japan, Republic of Korea, Norway, Peru, Sweden, United Arab Emirates, and the United Kingdom.
The recall was initiated because an out-of-tolerance torque tool was used on three joints during the manufacturing process. If the X-ray tube becomes loose on the CT gantry during operation, it could result in beam tracking errors, potential scan aborts, and/or possible image artifacts. The source notes that a secondary safety mechanism is present to prevent components from being expelled from the gantry if the bolts fail.
Healthcare facilities and consumers with these specific systems should contact GE Medical Systems for further instructions on how to address the issue. The recall number is Z-1589-2016.
The recalled product
- Product
- GE, Revolution CT. The system is intended for head, whole body, cardiac, and vascular X-ray Computed Tomography applications
- Manufacturer
- GE Medical Systems, LLC
Distribution
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