Date Initiated by Firm |
December 03, 2019 |
Date Posted |
April 24, 2020 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1709-2020 |
Recall Event ID |
85466 |
510(K)Number |
K052581
|
Product Classification |
Densitometer, bone - Product Code KGI
|
Product |
Lunar iDXA 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
|
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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 AND PRIMARY CARE DIA
|