CLASS II ONGOING Device recall · Reported 6 May 2020 · FDA Enforcement Report
Lunar iDXA Pro/Lunar iDXA Advance (iDXA recalled by GE Healthcare
GE Healthcare is recalling Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v18) bone densitometer, distributed nationwide in the US. The recall was initiated on 3 Dec 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1712-2020
- FDA event ID
- 85466
- Recalling firm
- GE Healthcare, Waukesha, WI
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 3 Dec 2019
- FDA classified
- 24 Apr 2020
- Reported
- 6 May 2020
- Type
- FDA Mandated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 3 Dec 2019 | Recall initiated by company | |
| 24 Apr 2020 | Classified by FDA | +143 days |
| 6 May 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence.
Product as listed by the FDA
Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v18) bone densitometer
Where it was distributed
US Nationwide Distribution
Questions about this recall
Is Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v18) bone densitometer recalled?
Yes. GE Healthcare recalled Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v18) bone densitometer on 3 Dec 2019. The recall is Class II and its status is Ongoing. Recall number Z-1712-2020.
Why was it recalled?
An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence.
Which lots are affected?
all affected systems
Where was it sold?
US Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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