PlainRecalls
FDA Devices Moderate Class II Ongoing

Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v18) bone densitometer

Reported: May 6, 2020 Initiated: December 3, 2019 #Z-1712-2020

Product Description

Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v18) bone densitometer

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.

Details

Recalling Firm
GE Healthcare, LLC
Units Affected
123 in total
Distribution
US Nationwide Distribution
Location
Waukesha, WI

Frequently Asked Questions

What product was recalled?
Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v18) bone densitometer. Recalled by GE Healthcare, LLC. Units affected: 123 in total.
Why was this product 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 agency issued this recall?
This recall was issued by the FDA Devices on May 6, 2020. Severity: Moderate. Recall number: Z-1712-2020.