Z-1711-2020 Class II Ongoing
FDA device recall Z-1711-2020 was initiated by GE Healthcare, LLC on December 3, 2019 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 123 in total.
Recall Details
- Product Type
- Devices
- Report Date
- May 6, 2020
- Initiation Date
- December 3, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 123 in total
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.
Distribution Pattern
US Nationwide Distribution
Code Information
all affected systems