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Lunar iDXA Advance (iDXA with enCORE v16) bone densitometer recallZ-1710-2020 · GE Healthcare, LLC · initiated Dec 3, 2019

Class II Open, Classified All recalls posted in April 2020

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from GE Healthcare, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Radiation Control for Health and Safety Act

What the company is doing

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.

Recall details

Recall number
Z-1710-2020
Recall class
Class II
Status
Open, Classified
Initiated by the company
Dec 3, 2019
Posted by the FDA
Apr 24, 2020
Recalling firm
GE Healthcare, LLC
Quantity
123 in total
Product code
KGI
FDA submissions
K133664
Distribution
US Nationwide Distribution

Product description

Lunar iDXA Advance (iDXA with enCORE v16) bone densitometer

Code information (models, lots, serial numbers)

all affected systems

Other devices under the same FDA submission

1 device cleared under K133664 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 85466).

Sources and updates

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