Device product

Lunar iDXA Advance (iDXA with enCORE v16) bone densitometer

Z-1710-2020

December 03, 2019

Class II

Product summary

Firm: GE Healthcare, LLC
Event: Event 85466
Status: Ongoing
Classification: Class II
Quantity: 123 in total
Official record key: device-enforcement:Z-1710-2020

Official wording

Reason: An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence.

Code information: all affected systems

Distribution pattern: US Nationwide Distribution

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence.