GE Healthcare Recalls Lunar iDXA Bone Densitometers Due to Radiation Risk
GE Healthcare is recalling 123 Lunar iDXA bone densitometers because a control panel defect may cause the start button to stick, potentially leading to accidental radiation 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: The recall involves a risk-of-harm product (radiation exposure) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products without reported illness.
Plain-English summary
GE Healthcare, LLC is recalling 123 Lunar iDXA Pro and Lunar iDXA Advance bone densitometers (iDXA with enCORE v18) distributed nationwide in the United States. The recall is due to a defect in the Lunar iDXA control panel that may cause the start button to fail to release. This malfunction could potentially contribute to an accidental radiation occurrence.
The recall affects all affected systems. No specific dates, lot numbers, or additional distribution details are provided in the source text. Consumers and healthcare providers should contact GE Healthcare for further instructions on how to address this issue.
The recalled product
- Product
- Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v18) bone densitometer
- Manufacturer
- GE Healthcare, LLC
- Hazard
- Affected units
- 123
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)
- all affected systems
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 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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