Discovey C

Hologic, Inc. · Model Discovery C · UDI-DI 15420045506909

KGI Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

The Discovery series bone densitometers are computer-assisted X-Ray scanners used to aid a physician in measuring bone mineral density (BMD) and determining fracture risk. All Discovery Series densitometers allow comparison of estimated BMD from a subject's proximal femur (hip), lumbar spine, and forearm to reference data for sex and ethnicity matched controls. Discovery Wi, W, and A models can also be used for estimating the lean body mass and fat mass of non-osseous tissues. Discovery C, W, SL, and A models can be used for performing a visual or quantitative assessment of vertebral bodies for diagnosis of vertebral deformity. Discovery SL and A models are capable of measuring the lateral vertebral BMD in the supine lateral position.

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.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

Data 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.