66 results
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33ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Merge OrthoCase software. The firm name on the label is Merge Healthcare, Hartland, WI.
FDA Enforcement
Class II
·Terminated·Merge Healthcare, Inc.·December 28, 2016
Merge OrthoCase software. The firm name on the label is Merge Healthcare, Hartland, WI.
FDA Recall
Terminated
·Merge Healthcare, Inc.·Product code LLZ·October 8, 2015
Stryker Navigation System - OrthoMap 3D (Sales Demos), Part number 81-81016. It provides precise stereostatic determination of surgical targets using stereostatic methodology. The three principle features include computer calculation of stereostatic coordinates from the diagnostic images, measurement of the stereostatic coordinates within the surgical field, high-resolution computer display or diagnostic images with stereostatic coordinates indicated. The system is comprised of software and hardware components.
FDA Recall
Terminated
·Stryker Instruments Division of Stryker Corporation·Product code HAW·November 10, 2010
Stryker Navigation System - OrthoMap 3D Module, Part number 6005-650-000. It provides precise stereostatic determination of surgical targets using stereostatic methodology. The three principle features include computer calculation of stereostatic coordinates from the diagnostic images, measurement of the stereostatic coordinates within the surgical field, high-resolution computer display or diagnostic images with stereostatic coordinates indicated. The system is comprised of software and hardware components.
FDA Recall
Terminated
·Stryker Instruments Division of Stryker Corporation·Product code HAW·November 10, 2010
Stryker Navigation System - OrthoMap 3D - Enable, Part number 6005-650-300. It provides precise stereostatic determination of surgical targets using stereostatic methodology. The three principle features include computer calculation of stereostatic coordinates from the diagnostic images, measurement of the stereostatic coordinates within the surgical field, high-resolution computer display or diagnostic images with stereostatic coordinates indicated. The system is comprised of software and hardware components.
FDA Recall
Terminated
·Stryker Instruments Division of Stryker Corporation·Product code HAW·November 10, 2010
Stryker Navigation System - OrthoMap 3D - Enable, Part number 6002-650-300. It provides precise stereostatic determination of surgical targets using stereostatic methodology. The three principle features include computer calculation of stereostatic coordinates from the diagnostic images, measurement of the stereostatic coordinates within the surgical field, high-resolution computer display or diagnostic images with stereostatic coordinates indicated. The system is comprised of software and hardware components.
FDA Recall
Terminated
·Stryker Instruments Division of Stryker Corporation·Product code HAW·November 10, 2010
Stryker Navigation System - OrthoMap 3D - Planning, Part number 6005-651-000. It provides precise stereostatic determination of surgical targets using stereostatic methodology. The three principle features include computer calculation of stereostatic coordinates from the diagnostic images, measurement of the stereostatic coordinates within the surgical field, high-resolution computer display or diagnostic images with stereostatic coordinates indicated. The system is comprised of software and hardware components.
FDA Recall
Terminated
·Stryker Instruments Division of Stryker Corporation·Product code HAW·November 10, 2010
VITROS ECi/ECiQ Immunodiagnostic System Product Code: 1922814 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code KHO·February 20, 2019
VITROS ECi Immunodiagnostic System Refurbished Product Code: 6801059 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code KHO·February 20, 2019
VITROS 3600 Immunoassay System Refurbished-Software V3.3.2 & below Product Code: 6802914 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code JJE·February 20, 2019
VITROS 5600 Integrated System Refurbished-Software V3.3.2 & below Product Code: 6802915 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code JJE·February 20, 2019
VITROS 5600 Integrated System -Software V3.3.2 & below Product Code: 6802413 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code JJE·February 20, 2019
VITROS XT 7600 Integrated System-Software V3.4.1 & below Product Code: 6844461 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code JJE·February 20, 2019
VITROS 3600 Immunoassay System-Software V3.3.2 & below Product Code: 6802783 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code JJE·February 20, 2019
VITROS XT 7600 Integrated System Software Versions 3.5.1 and below Product Code:6844461 Unique Identifier: 10758750031610
FDA Recall
Terminated
·Ortho Clinical Diagnostics·Product code JJE·May 20, 2020
VITROS 5600 Integrated System Software Versions 3.3.3 and below Product Code: 6802413 Unique Identifier: 10758750002740
FDA Recall
Terminated
·Ortho Clinical Diagnostics·Product code JJE·May 20, 2020
VITROS 5600 Integrated System - Refurbished Software Versions 3.3.3 and below Product Code: 6802915 Unique Identifier: 10758750007110
FDA Recall
Terminated
·Ortho Clinical Diagnostics·Product code JJE·May 20, 2020
VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2, Catalog Number 1453489 For in vitro diagnostic use only For the quantitative measurement of vitamin B12 in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System, to aid in the differential diagnosis of anemia
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code CDD·August 28, 2018
VITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below Product Code: 6802783, Unique Identifier: 10758750002979
FDA Recall
Terminated
·Ortho Clinical Diagnostics·Product code JJE·May 20, 2020
VITROS 3600 Immunodiagnostic System - Refurbished Product Code: 6802914 Unique Identifier: 10758750007103
FDA Recall
Terminated
·Ortho Clinical Diagnostics·Product code JJE·May 20, 2020