FDA recall Z-1712-2020

Product

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.

Distribution

US Nationwide Distribution

Key facts

Status

Ongoing

Initiation date

2019-12-03

Report date

2020-05-06

Voluntary/Mandated

FDA Mandated

Location

Waukesha, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1712-2020