GE Healthcare Recalls Lunar iDXA Advance Bone Densitometers Due to Radiation Risk
GE Healthcare is recalling 123 Lunar iDXA Advance bone densitometers because a control panel issue may cause the start button to stick, potentially leading to accidental radiation exposure.
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: The recall involves a risk-of-harm product (radiation exposure) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
GE Healthcare, LLC is recalling 123 Lunar iDXA Advance (iDXA with enCORE v16) bone densitometers. The recall covers all affected systems distributed nationwide in the United States.
The recall was issued because an issue with the Lunar iDXA control panel may cause the start button to not release. This malfunction could potentially contribute to an accidental radiation occurrence.
Healthcare facilities and consumers who have these devices should contact GE Healthcare for instructions on how to resolve the issue. The source text does not specify a particular action for end-users, but the device should be handled according to the manufacturer's guidance to prevent unintended radiation exposure.
The recalled product
- Product
- Lunar iDXA Advance (iDXA with enCORE v16) 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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