GE Healthcare recalls Lunar iDXA Advance bone dens: Control panel issue may cause accidental radiation exposure. Affected units include all systems with enCORE v16 software.
An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence.
GE Healthcare is recalling all Lunar iDXA Advance bone densitometers with enCORE v16 software due to a potential control panel issue that could cause the start button to not release, risking accidental radiation exposure. This poses a radiation hazard during use, requiring immediate attention to prevent unintended radiation events.
The control panel issue can cause the start button to remain engaged, potentially allowing radiation to be emitted during scans without the user's awareness. This could lead to accidental radiation exposure if the device is used without proper safety checks.
Medical facilities using the Lunar iDXA Advance bone densitometer with enCORE v16 software are most at risk. Patients undergoing bone density scans with this device may be exposed to unintended radiation.
Check if your bone densitometer has the model name 'Lunar iDXA Advance' and software version 'enCORE v16'. All affected systems are included in this recall.
Verify your device's software version to confirm if it is enCORE v16.
Reach out to GE Healthcare for specific instructions on addressing the issue.
Yes, if your device is a Lunar iDXA Advance with enCORE v16 software, it is affected by this recall.
Check for the model name 'Lunar iDXA Advance' and software version 'enCORE v16' on your device.
Contact GE Healthcare for specific instructions on addressing the issue.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1710-2020 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-1710-2020 from GE Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.