GE Healthcare Revolution CT collimator blade malfunction causing radiation dose variance
GE Healthcare is recalling Revolution CT systems where a collimator blade malfunction may cause x-ray radiation doses to be delivered in amounts larger or smaller than prescribed.
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: FDA Class II recall involving risk-of-harm imaging equipment that could deliver incorrect radiation doses. No illnesses or injuries are reported in the source material, keeping the score at the upper boundary of risk-of-harm recalls without documented patient harm.
Plain-English summary
GE Healthcare has identified a potential issue affecting Revolution CT imaging systems in which the collimator blade fails to locate its appropriate home position. When this malfunction occurs, the system may deliver x-ray radiation doses that differ from the prescribed value, potentially exposing patients to either excessive or insufficient radiation.
Approximately 197 Revolution CT systems have been distributed globally, with 40 units in the United States and 157 units internationally. Affected systems are identified by the code 5590000, 5590000-6, and 5590000-2.
Healthcare facilities operating Revolution CT systems should contact GE Healthcare for guidance on inspection and remediation of affected equipment. No corrective actions have been detailed in the recall notice at this time.
The recalled product
- Product
- Revolution CT
- Manufacturer
- GE Healthcare, LLC
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)
- 5590000 5590000-6 5590000-2
Distribution
Distributed nationwide across the United States.
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