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Elite
Norland at Swissray · Model Elite · UDI-DI 00866955000461
KGI
Prescription
10
510(k) clearances
57
Adverse events
26
Recalls
23
Facilities
Description
Elite Bone Densitometer
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-02-03 | Medimaps Group | Potential variability in calculations from fast array scans compared to array scans when operating on Hologic Horizon machines. |
| 2024-06-13 | Hologic Inc | Non-conformance pertains to electromagnetic compatibility requirements according to the international technical standard IEC 60601-1-2 for the safety and essential performance of m |
| 2019-12-03 | GE Healthcare, LLC | An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence. |
| 2019-12-03 | GE Healthcare, LLC | An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence. |
| 2019-12-03 | GE Healthcare, LLC | An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence. |
| 2019-12-03 | GE Healthcare, LLC | An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence. |
| 2018-03-16 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LL | Under certain conditions, when using DICOM Worklist along with DICOM MPPS, a report for a bone density exam may be sent to PACS with the incorrect patient information in the DICOM |
| 2018-03-16 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LL | Under certain conditions, when using DICOM Worklist along with DICOM MPPS, a report for a bone density exam may be sent to PACS with the incorrect patient information in the DICOM |
| 2018-03-16 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LL | Under certain conditions, when using DICOM Worklist along with DICOM MPPS, a report for a bone density exam may be sent to PACS with the incorrect patient information in the DICOM |
| 2016-10-03 | Medimaps Group | The FRAX adjusted for TBS values are not correct when: The FRAX feature is activated in TBS iNsight; and TBS has been computed from a spine scan where some vertebrae were excluded. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.