PlainRecordsFDA · Medical device recall
Lunar iDXA bone densitometer and 3 more products
- Date
- May 6, 2020
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
- Status
- Ongoing
- Filed by
- GE Healthcare, LLC
- 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.
- Distribution pattern
- US Nationwide Distribution
4 products in this recall
Lunar iDXA bone densitometer
- Product
- Lunar iDXA bone densitometer
- Quantity
- 123 in total
- Codes and lots
- all affected systems
- Recall started
- Dec. 3, 2019
- Device type
- Densitometer, Bone
- Root cause (FDA)
- Radiation Control for Health and Safety Act
- What the company told customers
- 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 number
- Z-1709-2020
Lunar iDXA Advance (iDXA with enCORE v16) bone densitometer
- Product
- Lunar iDXA Advance (iDXA with enCORE v16) bone densitometer
- Quantity
- 123 in total
- Codes and lots
- all affected systems
- Recall started
- Dec. 3, 2019
- Device type
- Densitometer, Bone
- Root cause (FDA)
- Radiation Control for Health and Safety Act
- What the company told customers
- 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 number
- Z-1710-2020
Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v17) bone densitometer
- Product
- Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v17) bone densitometer
- Quantity
- 123 in total
- Codes and lots
- all affected systems
- Recall started
- Dec. 3, 2019
- Device type
- Densitometer, Bone
- Root cause (FDA)
- Radiation Control for Health and Safety Act
- What the company told customers
- 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 number
- Z-1711-2020
Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v18) bone densitometer
- Product
- Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v18) bone densitometer
- Quantity
- 123 in total
- Codes and lots
- all affected systems
- Recall started
- Dec. 3, 2019
- Device type
- Densitometer, Bone
- Root cause (FDA)
- Radiation Control for Health and Safety Act
- What the company told customers
- 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 number
- Z-1712-2020
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-1709-2020, Z-1710-2020, Z-1711-2020, Z-1712-2020. The agency record governs; check it and the company before acting.