X-Ray Imaging System May Continue Exposure Beyond Safety Limit
GE Medical Systems' Optima XR646 HD X-Ray imaging systems may allow continued radiation exposure beyond the safety limit without operator confirmation. A warning message displays but does not prevent the excess exposure.
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: This is a Class II medical device recall involving a malfunction in the radiation exposure safety mechanism. No illnesses or injuries have been reported, but the hazard involves potential uncontrolled radiation exposure, qualifying as a risk-of-harm product without reported injury per the severity rubric.
Plain-English summary
GE Medical Systems, LLC is recalling the Optima XR646 HD X-Ray imaging system due to a malfunction in its radiation exposure control mechanism.
The system is designed with an Automatic Exposure Control (AEC) that limits radiation exposure. However, operators can continue to take additional radiation exposure after the AEC limit is reached without taking any further action to acknowledge or adjust exposure techniques. Although a message appears on the screen when the limit is reached, it does not prevent the device from continuing the exposure beyond the intended safety threshold.
The recall involves 3,149 units distributed worldwide, including 1,697 units in the United States and Puerto Rico and 1,452 units distributed to other countries.
Healthcare facilities using this equipment should contact GE Medical Systems, LLC for information regarding this issue.
The recalled product
- Product
- Optima XR646 HD. X-Ray imaging system.
- Manufacturer
- GE Medical Systems, 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)
- GTIN: 00195278526892
Distribution
Part of a larger recall action
This product is one of 4 recalled by GE Medical Systems, 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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