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Recall Observatory FDA recall evidence

Device product

Lunar iDXA bone densitometer

Z-1709-2020

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-1709-2020

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.