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Stratec Medizintechnik GmbH · Model XCT 3000 · UDI-DI 04260491560025

510(k) clearances

Adverse events

Recalls

Facilities

Description

Peripheral quantitative computed tomograph for the measurement at femur, radius or tibia. Evaluation of volumetric bone density, bone geometry and muscle parameter at the forarm, upper or lower leg using peripheral quantitative computes tomography.

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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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.