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U.S. Department of Health and Human Services

Class 2 Device Recall Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v18)

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  Class 2 Device Recall Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v18) see related information
Date Initiated by Firm December 03, 2019
Date Posted April 24, 2020
Recall Status1 Open3, Classified
Recall Number Z-1712-2020
Recall Event ID 85466
510(K)Number K191112  
Product Classification Densitometer, bone - Product Code KGI
Product Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v18) bone densitometer
Code Information all affected systems
Recalling Firm/
Manufacturer		 GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact GE HEALTHCARE SERVICE
800-437-1171
Manufacturer 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.
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
Action GE Healthcare notified customers via an Electronic Product Radiation Warning Letter dated March 13, 2020. The letter provided the following instructions. 1) Discontinue use of the start button on the control panel of the Lunar iDXA system to start a scan until a GE Representative can correct your system. 2) Disable the control panel start button in the enCORE software by following the below steps: " In enCORE, select menu item Tools> User Options. " Select the measure tab. " Uncheck the option "Allow Scanner Start Button to initiate a Measurement " " Press OK. 3) Start the patient scan from the measure screen of the enCORE software. GE Healthcare will correct all affected Lunar iDXA systems by inspecting and replacing, if necessary, the iDXA control panel at no cost to the customer. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Quantity in Commerce 123 in total
Distribution US Nationwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = KGI and Original Applicant = GE Medical Systems Ultrasound & Primary Care Diagnostics LLC
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