21 results
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10ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Alinity m Integrated Reaction Units (IRU)
FDA Recall
Terminated
·Abbott Molecular, Inc.·Product code OOI·February 11, 2022
Alinity m Integrated Reaction Units (IRU)
FDA Enforcement
Class II
·Terminated·Abbott Molecular, Inc.·March 9, 2022
QRS Diagnostic Universal ECG 12 Channel ECG (IEC), Rx only, REF Z-7000-0400, Manufactured for QRS Diagnostic, 14755 27th Ave North, Plymouth, MN 55447 USA. Product Usage: The Universal ECG is an Electrocardiograph Diagnostic System designed to provide measurements and interpretative statements of a patients ECG waveform. The interpreted ECG with measurements and diagnostic statements are provided to the physician on an advisory basis only, for the physician to over read and validate or change the ECG interpretation. The ECG measurements and interpretive statements may be reviewed, edited, distributed electronically or printed. No real time monitoring or alarm capability is provided.
FDA Recall
Terminated
·Qrs Diagnostic·Product code LOS·February 16, 2012
Esprit Power Supply Snubber Board Assembly FRU, PN 1036236 The Esprit Ventilator is a microprocessor controlled, electrically powered, mechanical ventilator.
FDA Recall
Terminated
·Respironics California Inc·Product code CBK·January 25, 2008
Esprit Power Supply Field Replacement Unit (FRU), PN 101 8246 The Esprit Ventilator is a microprocessor controlled, electrically powered, mechanical ventilator.
FDA Recall
Terminated
·Respironics California Inc·Product code CBK·January 25, 2008
Esprit Ventilator, Model Number V1000, Power Supply PN 1015852 and Power Supply Field Replacement Unit (FRU) PN, Continuous Ventilator/Continuous Ventilator with Respiratory Mechanics 1018246
FDA Recall
Terminated
·Respironics California Inc·Product code CBK·August 8, 2006
GE Healthcare, NeuroMuscular Transmission Module, E-NMT-01 Product Usage: The Datex-Ohmeda S/5TM E-NMT module is indicated for monitoring the relaxation of the patient and regional block stimulation for nerve location.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code KOI·April 9, 2014
Abbott brand CELL-DYN Emerald, CELL-DYN Emerald CPU Board Hematology System; List Number: 09H39-01; Field Replaceable Unit (FRU) Numbers: 8701686901, 8701686902; Product is distributed by Abbott Diagnostics Division, Santa Clara. CA and manufactured in France for Abbott Diagnostics Division of Abbott Laboratories, Abbott Park, IL Intended use: The CELL-DYN Emerald is an automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories.
FDA Recall
Terminated
·Abbott Laboratories·Product code GKZ·October 15, 2010
Hemospray Endoscopic Hemostat
FDA Recall
Terminated
·Wilson-Cook Medical Inc.·Product code QAU·July 24, 2019
Pelton & Crane Spirit 3000 dental chair (Model #SP30)
FDA Recall
Terminated
·Pelton & Crane Company·Product code NRU·March 4, 2011
Pelton & Crane Spirit 1800 dental chair (Model #SP18)
FDA Recall
Terminated
·Pelton & Crane Company·Product code NRU·March 4, 2011
HEMO-10 Hemospray Endoscopic Hemostat
FDA Recall
Terminated
·Wilson-Cook Medical Inc.·Product code QAU·February 4, 2020
HEMO-7 Hemospray Endoscopic Hemostat
FDA Recall
Terminated
·Wilson-Cook Medical Inc.·Product code QAU·February 4, 2020
The magnetic headrest is designed to fit the following dental chairs (THE HEADREST IS THE RECALLED ITEM, NOT THE CHAIRS): The dental chairs are sold under the brand names Marus and DCI Equipment. The affected models are: Marus MaxStar-Agency Model # DC1490; Marus MaxStar-Agency Model # DC1690; Marus NuStar-Agency Model # DC1700; Marus NuStar-Agency Model # DC1702; Marus ProStar-Agency Model # DC1540; Marus ProStar-Agency Model # DC1535; DCI Equipment DC1235 Hydraulic-Agency Model # DC1235; and DCI Equipment DC1335 Electromechanical-Agency Model # DC1335.
FDA Recall
Terminated
·Dental Equipment LLC·Product code NRU·March 23, 2010
Dental chairs distributed under several brand names such as DCI Equipment; Marus MaxStar; Marus NuStar; and Pelton & Crane. Part number for the bolt: 022R065 Product is labeled in part: DCI Equipment, Mfg By: Dental Equipment, LLC. DC1235, Marus Dental, Mfg By: Dental Equipment, LLC. DC1490, DC1690, and DC1700, and DC1702, Pelton & Crane, Spirit SP17.
FDA Recall
Terminated
·Dental Equipment LLC·Product code NRU·March 1, 2011
Medtronic DBS Therapy for Dystonia Kit, models 3317, 3319, 3337 and 3339. Sterile and Non-Pyrogenic. Product Usage: Dystonia Therapy Kit is indicated for unilateral or bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) to aid in the management of chronic, intractable (drug refractory) primary dystonia, including generalized and/or segmental dystonia, hemidystonia, and cervical dystonia (torticollis).
FDA Recall
Terminated
·Medtronic Neuromodulation·Product code MRU·February 8, 2013
ZYMUTEST HIA MonoStrip IgG; REF Number: RK041A; UDI: 03663537046803 a qualitative assay intended for the detection of heparin-dependent antibodies of the IgG isotype, in human plasma, by clinical laboratories. It is intended for in vitro diagnostic use.
FDA Recall
Terminated
·Hyphen BioMed 155 rue d Eragny Neuville Sur Oise France·Product code LCO·February 5, 2018
ZYMUTEST HIA MonoStrip IgGAM. Model Number: RK041D. Qualitative screening assay for the detection of heparin-dependent antibodies (IgG, IgM and IgA isotypes by ELISA. 32 Tests.
FDA Recall
Terminated
·Hyphen BioMed 155 rue d Eragny Neuville Sur Oise France·Product code LCO·November 9, 2011
ZYMUTEST HIA IgGAM. Model Number: RK040D. Qualitative screening assay for the detection of heparin-dependent antibodies (IgG, IgM and IgA isotypes by ELISA. 96 Tests.
FDA Recall
Terminated
·Hyphen BioMed 155 rue d Eragny Neuville Sur Oise France·Product code LCO·November 9, 2011
ZYMUTEST HIA MonoStria qualitative screening assay intended for the global detection of heparin-dependent antibodies, whether the isotype is: IgG, IgM and IgA, in human plasma, by clinical laboratories. p IgGAM; REF Number: RK041D; UDI: 03663537046810
FDA Recall
Terminated
·Hyphen BioMed 155 rue d Eragny Neuville Sur Oise France·Product code LCO·February 5, 2018