Densitometer, Bone
Radiology · 21 CFR 892.1170
Recent MDR events
57 adverse event reports on file
- PRODIGYDec 22, 2025InjuryGe Medical Systems Monterrey Mexico, S.a. De C.v.9616047-2025-00002
- HORIZONNov 10, 2025MalfunctionHologic Inc3005496266-2025-00093
- HORIZONOct 23, 2025MalfunctionHologic Inc3005496266-2025-00077
- HORIZONOct 22, 2025InjuryHologic, Inc3005496266-2025-00078
- HORIZONOct 21, 2025MalfunctionHologic, Inc3005496266-2025-00076
- HOLOGIC DEXA SCANNEROct 6, 2025MalfunctionHologic, Inc.MW5176923
- GE LUNAR BONE DENSITOMETERMay 5, 2025InjuryGe Medical Systems Ultrasound & Primary Care Diagnostics Llc.MW5169944
- DEXA SCAN HORIZON WJan 2, 2025MalfunctionHologic, Inc.MW5164099
- HOLOGIC HORIZON WDec 27, 2024MalfunctionHologic, Inc.MW5164060
- HORIZONSep 6, 2024MalfunctionHologic, Inc1220984-2024-00102
Event type breakdown
Recalls
26 recall events for this product code
- Medimaps GroupOpen, ClassifiedFeb 28, 2025
Brand Name: TBS Osteo
Potential variability in calculations from fast array scans compared to array scans when operating on Hologic Horizon machines.
Z-1250-2025 · View FDA record ↗ - Hologic IncOpen, ClassifiedJul 16, 2024
Horizon X-Ray Bone Densitometer (DXA)
Non-conformance pertains to electromagnetic compatibility requirements according to the international technical standard IEC 60601-1-2 for the safety and essential performance of medical electrical equipment, where the result from the Horizon DXA System exceeded the limit for acceptability.
Z-2373-2024 · View FDA record ↗ - GE Healthcare, LLCOpen, ClassifiedApr 24, 2020
Lunar iDXA bone densitometer
An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence.
Z-1709-2020 · View FDA record ↗ - GE Healthcare, LLCOpen, ClassifiedApr 24, 2020
Lunar iDXA Advance (iDXA with enCORE v16) bone densitometer
An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence.
Z-1710-2020 · View FDA record ↗ - GE Healthcare, LLCOpen, ClassifiedApr 24, 2020
Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v17) bone densitometer
An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence.
Z-1711-2020 · View FDA record ↗ - GE Healthcare, LLCOpen, ClassifiedApr 24, 2020
Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v18) bone densitometer
An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence.
Z-1712-2020 · View FDA record ↗ - Medimaps GroupTerminatedNov 5, 2016
TBS iNsight Version v.3.0.1
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.
Z-0369-2017 · View FDA record ↗ - Cooper Surgical, Inc.TerminatedNov 18, 2011
DICOM Option for the Norland Illuminatus Software Revs 4.2.0 though 4.3.1. Models Norland XR-600, XR-800, XR-46, EXCELL, XR-36 and Eclipse DXA Bone Densitometer
The DICOM Software, Norland Illuminatus DXA Software with the DICOM Option (Part Number 434A133) version 4.2.0 through 4.3.1, which is installed on the XR-600, XR-800, XR-46 and EXCELL DXA Bone Densitometers, could lead to improper patient information getting into a previous patient's record.
Z-0213-2012 · View FDA record ↗ - Ge HealthcareTerminatedJan 27, 2010
iDXA, GE Lunar DEXA bone densitometers operating with enCORE software versions 12.0, 12.1, 12.2,13.0, & 13.1.
Failure to properly pre-indicate the technique factors to be used during a patient scan.
Z-0600-2010 · View FDA record ↗ - Ge HealthcareTerminatedJan 27, 2010
Prodigy 1-8 series, GE Lunar DEXA bone densitometers operating with enCORE software versions 12.0, 12.1, 12.2,13.0, & 13.1.
Failure to properly pre-indicate the technique factors to be used during a patient scan.
Z-0601-2010 · View FDA record ↗
Registered firms
51 firms currently registered for this product code
Can Technomed Trading Ltd.
Richmond British Columbia, CA
Ge Medical Systems Ultrasound & Primary Care Diagnostics Llc
MADISON, WI, US
Block Imaging Parts & Service
Holt, MI, US
Lj Business Corporation
Chuo Tokyo, JP
Medimaps Group Sa
Plan-les-Ouates Geneve, CH
Siemens Healthineers Ag
FORCHHEIM Bavaria, DE
Ge Hangwei Medical Systems Co., Ltd.
Beijing, CN
Fujita Co., Ltd.
Chiyoda-ku Tokyo, JP
Flextronics Manufacturing Aguascalientes, S.a De C.v
Aguascalientes, MX
Block Imaging Sas
Weyersheim Bas-Rhin, FR
Bunkerhill Health
San Francisco, CA, US
Hologic, Inc.
Newark, DE, US
Mindways Software, Inc.
AUSTIN, TX, US
Heartlung Corporation
Houston, TX, US
Makar Consulting Pty Ltd
Belrose New South Wales, AU
Medimax-rsi, Llc
Caguas, PR, US
510(k) clearances
147 clearances for this product code
- GE Medical Systems Ultrasound & Primary Care Diagnostics, LLCApr 20, 2026
K252718 · Lunar Astra
- 3D-Shaper Medical S.LSep 5, 2025
K251022 · 3D-SHAPER
- BunkerHill HealthApr 8, 2025
K242295 · BunkerHill BMD
- Medimaps Group SAJan 17, 2025
K243218 · TBS iNsight (V4)
- O.N. DiagnosticsMay 19, 2023
K220402 · VirtuOst
- 3D-Shaper Medical S.LDec 9, 2022
K220822 · 3D-SHAPER
- HeartLung CorporationJul 29, 2022
K213760 · ABMD Software
- GE Medical Systems Ultrasound & Primary Care Diagnostics, LLCSep 19, 2019
K191112 · GEHC DXA Bone Densitometers with enCORE version 18