FDA recall Z-1709-2020

GE Healthcare, LLC · Class II · device

Product

Lunar iDXA 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-1709-2020