GE Healthcare Optima CT660 and CT680 X-ray Systems Recalled for Scan Timing Issue
GE Healthcare is recalling Optima CT660 and CT680 X-ray systems because a defect may cause scans to start before a prescribed delay completes.
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 involves a medical device where a defect could lead to unintended radiation exposure or procedural errors, representing a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
GE Healthcare, LLC is recalling 10,884 units of the Optima CT660 and CT680 X-ray systems. The recall was initiated after it was discovered that an issue exists which can result in a scan starting before the prescribed delay has completed.
The affected units were distributed worldwide, including nationwide in the United States (including Puerto Rico) and in numerous other countries. The source text does not specify any reported injuries, illnesses, or deaths associated with this defect.
Consumers and healthcare facilities with these devices should contact GE Healthcare for further instructions on how to resolve the issue. The source text does not provide specific contact details or remediation steps.
The recalled product
- Product
- GE Healthcare Optima CT660, CT680 X-ray system
- Manufacturer
- GE Healthcare, LLC
- Affected units
- 10,884
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)
- n/a
Distribution
Part of a larger recall action
This product is one of 16 recalled by GE Healthcare, 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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