158 results
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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The eCareManager system. Software intended for use in data collection, storage and clinical information management with independent bedside devices, and ancillary systems that are connected either directly or through networks. For use in a hospital environment. eCareManager allows clinicians to generate a PDF display of an order (new, change, discontinue), which is printed at the bedside and/or hospital pharmacy. This printed PDF should be reviewed by the clinician and verified by the hospital pharmacist and entered into the hospital pharmacy system.
FDA Enforcement
Class II
·Terminated·Visicu, Inc.·December 16, 2015
IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs (including XML style sheet customization and PDF)
FDA Recall
Terminated
·AGFA Corp.·Product code LLZ·July 27, 2012
IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs (including XML style sheet customization and PDF)
FDA Enforcement
Class II
·Terminated·AGFA Corp.·August 22, 2012
Case Cardiac Assessment System for Exercise Testing and CardioSoft Diagnostic System Exercise Stress Testing ECG application
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·June 30, 2021
SoftGenomics version 4.1.15.6 SoftGenomics is a laboratory workflow and information management system to be used in a clinical molecular or cytogenetics laboratory or medical research laboratory setting by knowledgeable and trained users. SoftGenomics is used to record and track activities performed in ordering, specimen processing (pre-analytical steps), testing, documentation, and reporting.
FDA Enforcement
Class II
·Terminated·Soft Computer Consultants, Inc.·July 28, 2021
The eCareManager system. Software intended for use in data collection, storage and clinical information management with independent bedside devices, and ancillary systems that are connected either directly or through networks. For use in a hospital environment. eCareManager allows clinicians to generate a PDF display of an order (new, change, discontinue), which is printed at the bedside and/or hospital pharmacy. This printed PDF should be reviewed by the clinician and verified by the hospital pharmacist and entered into the hospital pharmacy system.
FDA Recall
Terminated
·Visicu, Inc.·Product code MSX·March 27, 2015
IMPAX, PACS, Picture Archive and Communications System, IMPAX CV 7.8.x and IMPAX CV 12.x. Corrects certain demographic information (Patient Name, Patient Medical Record Number and/or Accession Number in previously signed reports that have since changed.
FDA Enforcement
Class II
·Terminated·AGFA Healthcare Corp.·November 25, 2015
CareLink iPro Version 1.10, Catalog No. MMT-7340 With data obtained from the iPro2 recorder and blood glucose meter, the CareLink iPro software retrospectively calibrates sensor data and provides reports of continuous glucose information. CareLink iPro reports show up to seven calendar days of study data. The reports are created in PDF format, so they can easily be printed or stored electronically.
FDA Enforcement
Class II
·Terminated·Medtronic Inc.·October 5, 2016
VERION Reference Unit (Vision Planner) Product Usage: The VERION Image Guided system is an advanced surgical planning, imaging and guidance technology designed to provide greater accuracy and efficiency during cataract surgery. It allows eye surgeons to capture a high-resolution, diagnostic reference image of the patients eye pre-operatively, quickly determine an optimized surgical plan that enables surgeons to see all inclusions and alignment in real-time.
FDA Enforcement
Class II
·Terminated·Alcon Research, Ltd.·April 20, 2016
CareLink iPro Version 1.10, Catalog No. MMT-7340 With data obtained from the iPro2 recorder and blood glucose meter, the CareLink iPro software retrospectively calibrates sensor data and provides reports of continuous glucose information. CareLink iPro reports show up to seven calendar days of study data. The reports are created in PDF format, so they can easily be printed or stored electronically.
FDA Recall
Terminated
·Medtronic Inc.·Product code PHV·August 5, 2016
Instrument Manager -Software Versions 8.05, 8.06, 8.07, 8.08, and 8.09. It is a stand-alone software package that provides connectivity between laboratory instruments and Laboratory Information Systems, aiding the flow of laboratory information, including test orders and results, specimen information, and patient information. Instrument Manager also provides data management functions that aid in the interpretation and management of laboratory results. The Instrument Manager software is put on a CD which is distributed in a box. User documentation consists of user manuals, PDF copies of which are on the CD Intended to be used by trained laboratory personnel as an aid in laboratory instrument interfacing and laboratory data management.
FDA Recall
Terminated
·Data Innovations, Inc.·Product code JQP·May 11, 2009
Tibial Total Ankle Prosthesis Tray, Size 3, Product No. LJU223T
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code HSN·March 8, 2019
Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Right, Product No. LJV180T
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code HSN·March 8, 2019
Talar Dome Total Ankle Prosthesis , Sloped, Size 1, Left, Product No. LJV191T
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code HSN·March 8, 2019
Talar Dome Total Ankle Prosthesis , Sloped, Size 1, Right, Product No. LJV181T
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code HSN·March 8, 2019
Talar Dome Total Ankle Prosthesis, Sloped, Size 2, Left, Product No. LJV192T
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code HSN·March 8, 2019
Tibial Total Ankle Prosthesis Tray, Size 2, Product No. LJU222T
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code HSN·March 8, 2019
Talar Dome Total Ankle Prosthesis , Sloped, Size 3, Left, Product No. LJV193T
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code HSN·March 8, 2019
Talar Dome Total Ankle Prosthesis, Sloped, Size 2, Right, Product No. LJV182T
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code HSN·March 8, 2019
Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Left, Product No. LJV190T
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code HSN·March 8, 2019