Recall Z-1711-2020— GE Healthcare, LLC

Name: FDA recall Z-1711-2020
Creator: U.S. Food and Drug Administration
Published: 2019-12-03

Class II · Ongoing

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2019-12-03. It names one FDA 510(k) clearance: K161682. Product: Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v17) bone densitometer. 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..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Ongoing
Initiated: 2019-12-03
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K161682 — GE Lunar DXA Bone Densitometers with enCORE version 17GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC·cleared 2016-12-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v17) 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.