32 results
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64ms
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Sources: EU EUDAMED, US FDA
ACCU-SED ABNORMAL ESR CONTROL
FDA Adverse Event
Other
·VITAL DIAGNOSTICS, INC.·Product code JJY·March 15, 2010
ENVOY 500 SERUM CONTROL 1 & 2
FDA Adverse Event
Injury
·VITAL DIAGNOSTICS INC.·Product code JJY·September 15, 2009
EQUINOX
FDA Adverse Event
Malfunction
·CAIRE INC.·Product code CAW·April 24, 2020
ATAC Serum Control Kit. The device is used for monitoring the performance of clinical chemistry methods within the clinical range.
FDA Recall
Terminated
·Vital Diagnostics, Inc.·Product code JJY·December 4, 2009
Envoy 500 Serum Control Kit. The device is used for monitoring the performance of clinical chemistry methods within the clinical range.
FDA Recall
Terminated
·Vital Diagnostics, Inc.·Product code JJY·December 4, 2009
Consult Diagnostics Eon Calcium Reagent For In-Vitro Diagnostic Use PN: 1429 For the quantitative measurement of calcium in plasma and serum
FDA Recall
Terminated
·Vital Diagnostics, Inc.·Product code CJY·August 29, 2013
Excyte Slider Barcode Tube Adapter used with Excyte Vacuum or Non-Vacuum ESR Tubes. Single Use. Product Number: EX-I0552. Manufactured by Vital Diagnostics S.R.L., Italy. Slider allows a larger label to be applied to the ESR tube.
FDA Recall
Terminated
·Vital Diagnostics, Inc.·Product code GHC·April 12, 2010
Vital Diagnostics Envoy Calcium Reagent For In-Vitro Diagnostic Use. PN 55285 For the quantitative measurement of calcium in plasma and serum
FDA Recall
Terminated
·Vital Diagnostics, Inc.·Product code CJY·August 29, 2013
Consult Diagnostics¿ Eon Calcium Reagent For In-Vitro Diagnostic Use PN: 1429 For the quantitative measurement of calcium in plasma and serum
FDA Enforcement
Class II
·Terminated·Vital Diagnostics, Inc.·January 22, 2014
Vital Diagnostics Envoy Calcium Reagent For In-Vitro Diagnostic Use. PN 55285 For the quantitative measurement of calcium in plasma and serum
FDA Enforcement
Class II
·Terminated·Vital Diagnostics, Inc.·January 22, 2014
2416455-1999-00003
FDA Adverse Event
Injury
·December 30, 1999
VitreaCore software. Versions subject to the limitation: 6.0, 6.1, 6.2, 6.3 (except 6.3.1 ), 6.4 (except 6.4.4 and 6.4.5), as well as their upgrades, and 6.5. The VitreaCore (ViTALConnect) system is a medical diagnostic software system intended to process, analyze, review, and distribute multi-dimensional digital Images acquired from a variety of imaging devices including: CT, MR, CR/DR/DX, SC, US, NM, PET, XA, and RF, etc. The VitreaCore (ViTALConnect) is not meant for primary Image Interpretation In mammography.
FDA Recall
Terminated
·Vital Images, Inc.·Product code LLZ·October 21, 2013
Vitrea (available in various configuration as Vitrea Enterprise Suite). Vitrea Enterprise Suite 1.2, Vitrea Enterprise Suite 1.3, Vitrea enterprise Suite 6.0 and Vitrea Enterprise Suite 6.1. A medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from variety of imaging devices.
FDA Recall
Terminated
·Vital Images, Inc.·Product code LLZ·November 11, 2011
Vital Images ViTALConnect , Version 4.0 and 4.1, PET/CT Visualization option. Vital Images, Inc., 5850 Opus Parkway, Suite 300, Minnetonka, MN 55343. ( A web-based medical diagnostic tool that allows physicians to use PCs or notebook computers to gain remote access to 2D, 3D, and 4D advanced visualization. The software enables users to measure, rotate, and analyze images)
FDA Recall
Terminated
·Vital Images, Inc.·Product code LLZ·November 8, 2007
GS 777 WALL TRANSFORMER US
FDA Adverse Event
Malfunction
·Product code HMF·August 18, 2021
Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX prior to version 6.3.3, except 6.1.6, 6.2.3 and 6.3 The software is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of multidimensional digital images acquired from a variety of imaging devices. It provides the ability to review digital images from original DICOM data for multiple modalities, including CT, MR, D, CR, XA, US, NM, PET, etc. The software is not meant for primary image interpretation in mammography.
FDA Recall
Terminated
·Vital Images, Inc.·Product code LLZ·February 5, 2013
Vital Connect 4.0 & 4.1, radiological image processing software A Medical diagnostic software system intended to process, analyze, review, and distribute multi-dimensional digital images acquired from a variety of imaging devices including: CT MR, CR/DR/DX, SC, US, NM, PET, XA and RF, etc. Vital connect has the following intended use: Vessel Probe is intended for viewing the anatomy and pathology of a patient's coronary arteries. Clinicians select any artery to view the following anatomical references: the highlighted vessel in 3D, two rotate-able curved MPR vessel views displayed at angles orthogonal to each other, and cross sections of the vessel.
FDA Recall
Terminated
·Vital Images, Inc.·Product code LLZ·August 23, 2010
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3B Product Description: M3B Vital Signs Monitor is a patient monitoring device providing the patient with a continuous vital physiological monitoring of arterial blood oxygen saturation (SpO2), Pulse Rate and CO2 in a hospital, hospital type facilities environment and intra-hospital moves. Component: No
FDA Recall
Open, Classified
·Edan Diagnostics·Product code DQA·October 24, 2025
NEXSYS PCS SYSTEM
FDA Adverse Event
Death
·HAEMONETICS, INC.·Product code GKT·March 29, 2022
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3s, iM3As, iM3Bs, iHM3s Product Description: The iM3s series vital signs monitors including iM3s/iM3As/iM3Bs/iHM3s are intended to be used for measuring, storing, reviewing of, and generating prompts for multiple physiological parameters of adults and pediatrics. Component: No
FDA Recall
Open, Classified
·Edan Diagnostics·Product code MWI·October 24, 2025