The Recall Desk
HighFDA (Devices)·Z-1709-2020·Announced 2020-05-06

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 or injury.

Plain-English summary

GE Healthcare, LLC is recalling 123 Lunar iDXA bone densitometers distributed nationwide in the United States. The recall was initiated due to a defect in the 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 of the Lunar iDXA bone densitometer. The source text does not specify particular lot numbers or serial numbers, indicating that the issue may apply to the units identified in the recall scope.

Consumers and healthcare facilities with these devices should contact GE Healthcare for instructions on how to resolve the issue. The source text does not provide specific contact details or remediation steps, so users should refer to the official FDA recall notice for further guidance.

The recalled product

Product
Lunar iDXA bone densitometer
Manufacturer
GE Healthcare, LLC
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.

See all 4 products in this recall →