CT Systems Recall: Improperly Loaded Software May Increase X-Ray Radiation
GE Healthcare is recalling Revolution EVO, Optima CT660, and Optima CT680 CT Systems due to improperly loaded software that may result in additional X-ray radiation exposure to patients.
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: FDA Class II recall involving software malfunction with potential for additional X-ray radiation exposure to patients. No illnesses or injuries are reported in the source. Per rubric criteria, this constitutes a risk-of-harm product without reported injury, warranting High severity.
Plain-English summary
GE Healthcare, LLC is recalling Revolution EVO, Optima CT660, and Optima CT680 CT Systems due to improperly loaded software options that may result in additional X-ray radiation exposure to patients.
Approximately 3,665 units have been distributed: 956 in the United States and 2,709 internationally. The affected devices are identified by specific hardware revision codes as documented in the recall information.
No illnesses or injuries have been reported in association with this software loading issue. The FDA classified this as a Class II recall due to the potential for increased patient radiation exposure during imaging procedures.
The recalled product
- Product
- Revolution EVO, Optima CT660, Optima CT680 CT Systems.
- Manufacturer
- GE Healthcare, LLC
- Affected units
- 3,665
Distribution
Distribution scope not specified by the agency.
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