BEUDAMED
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    Various GE Magnetic Resonance System on-site software version Product Usage: Magnetic resonance imaging equipment for general diagnostic use

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·January 16, 2019

    VITROS Anti-HBe Reagent Pack, Cat No. 6801816 Product Usage: For the in vitro qualitative detection of antibodies to hepatitis B e antigen (anti-HBe) in human adult and pediatric (2 to 21 years old) serum from individuals who have symptoms of chronic hepatitis and those who have recovered from HBV infection, using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System. Further assessment of HBV infection (biochemical, serological and/or nucleic acid testing) is required to define the specific disease state. VITROS Anti-HBe test performance has not been established for the monitoring of HBV disease or therapy. Test performance characteristics have not been established in patients under the age of 2, or in populations of immunocompromised or immunosuppressed patients. This test has not been FDA licensed for the screening of blood, plasma and tissue donors.

    FDA Enforcement
    Class II ·Ongoing·ORTHO-CLINICAL DIAGNOSTICS·January 9, 2019

    LIPOSORBER System, Model: LA-15, consisting of: Apheresis machine, product# 101445 model: MA-03, and disposables (product#, model) [#101447, KP-05 Sulflux Plasma Separator], [#101473, HDE KP-05 Sulflux Plasma Separator], [#101785, LA-15 (AU) LDL Adsorption Column (Luer Lock Type)], [#101786, NK-M3R(UL) Tubing (Luer Lock Type)], [#101788, HDE LA-15(AU) LDL Adsorption Column (Luer Lock Type)], [#101789, HDE NK-M3R(UL) Tubing (Luer Lock Type)]. Associated labeling: 1) Instructions for Use (6): IFU LIPOSORBER LA-15 LDL Adsorption Columns FH, IFU SULFLUX KP-05 PLASMA SE-PARATOR FH, IFU TUBING SYSTEM FOR PLASMAPHERESIS NK-M3R(UL) FH, IFU LIPOSORBER LA-15 LDL Adsorption Columns FSGS, IFU SULFLUX KP-05 PLASMA SE-PARATOR FSGS, IFU TUBING SYSTEM FOR PLASMAPHERESIS NK-M3R(UL) FSGS, 2) Operators Manuals for the following (2): LIPOSORBER LA-15 SYSTEM OPERATOR's MANUAL FH, LIPOSORBER LA-15 SYSTEM OPERATOR's MANUAL FSGS 3) Patients Guide (1): A PATIENT GUIDE TO THE LIPOSORBER LA-15 SYSTEM FSGS

    FDA Enforcement
    Class II ·Terminated·Kaneka America Corp·April 20, 2022

    GE Healthcare MR superconducting magnets, a component of GE Healthcare 1.5T SIGNA HDe MR System, nuclear magnetic resonance imaging system.

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare, LLC·February 16, 2022

    NeuRx Diaphragm Pacing System (NeuRx DPS), Affected part numbers: Part # Part Name 20-0035 NeuRx DPS System Kit 20-0036 NeuRx Diaphragm Pacing System, Patient Kit, SCI 20-0028 NeuRx DPS Surgical Kit, HDE 20-0040 NeuRx Diaphragm Pacing System Spare Sterile Components 21-0001-99 Mapping Probe 21-0004-99 Indifferent Electrode 21-0007-99 Lead Tunneler Set 21-0009-99 Blue Cable Set 21-0010-99 Transducer Tubing 21-0017-99 PermaLoc Electrode 21-0023-99 Green Cable 21-0024-99 Orange Cable 21-0025-99 Yellow Cable 21-0026-99 White Cable 77-0050 Surgeon Instruction Manual 20-0045 NeuRx DPS System Kit, ALS HDE 20-0046 NeuRx Diaphragm Pacing System, Patient Kit, ALS Marketed under HDE H070003 as well as H100006

    FDA Enforcement
    Class III ·Terminated·Synapse Biomedical Inc·July 27, 2022

    Vapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-Low. PF-DPC-Low packaged with compatible cannulas for evaluation of the Precision Flow system

    FDA Enforcement
    Class II ·Terminated·Vapotherm, Inc.·October 1, 2014

    GE Healthcare, GE 1.5T SIGNA HDe MR SYSTEM. Indicated for use as a diagnostic imaging device.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·May 8, 2013

    7F NeuroFlo Catheter, Model 1027 The NeuroFlo Catheter is a multi-lumen device with two balloons mounted near the distal tip for the treatment of cerebral ischemia resulting from symptomatic vasospasm following aneurysmal subarachnoid hemorrhage. The NeuroFlo Catheter is under Humanitarian Device Exemption and not commercially released under a premarket notification or premarket approval.

    FDA Enforcement
    Class II ·Terminated·ZOLL Circulation, Inc.·December 3, 2014

    Vapotherm Precision Flow,Disposable Patient Circuit PF-NODPC-Low. For use with the Precision Flow system and Ikaria INOmax DSIR ¿ System. This DPC allows clinicians to administer nitric oxide non-invasively via high flow nasal cannula. In the Precision Flow High Flow Therapy application, a special disposable patient circuit re-routes the gas to the INOmax injector module then back into the Precision Flow system

    FDA Enforcement
    Class II ·Terminated·Vapotherm, Inc.·October 1, 2014

    Vapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-High. For use with the Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital, sub-acute institutions, and home settings. It adds heat and moisture to blended medical air/oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula.

    FDA Enforcement
    Class II ·Terminated·Vapotherm, Inc.·October 1, 2014

    Vapotherm Precision Flow,Disposable Patient Circuit PFHDPC-Low. For use with the Heliox Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital, sub-acute institutions, and home settings. It adds heat and moisture to blended medical air/oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula.

    FDA Enforcement
    Class II ·Terminated·Vapotherm, Inc.·October 1, 2014

    Vapotherm Precision Flow,Disposable Patient Circuit PFH-DPC-High. For use with the Heliox Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital, sub-acute institutions, and home settings. It adds heat and moisture to blended medical air/oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula.

    FDA Enforcement
    Class II ·Terminated·Vapotherm, Inc.·October 1, 2014

    Vapotherm Precision Flow, Disposable Patient Circuit PF-DPC-High. For use with the Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital, sub-acute institutions, and home settings. It adds heat and moisture to blended medical air/oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula.

    FDA Enforcement
    Class II ·Terminated·Vapotherm, Inc.·October 1, 2014

    Vapotherm Precision Flow,Disposable Patient Circuit PF-DPC-Low. For use with the Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital, sub-acute institutions, and home settings. It adds heat and moisture to blended medical air/oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula.

    FDA Enforcement
    Class II ·Terminated·Vapotherm, Inc.·October 1, 2014

    Optima MR450w, Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant, and GE 1.5T Signa HDe MR System. The GE Signa HDx MR system is a whole body magnetic resonance scanner.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·March 20, 2013

    Vapotherm Precision Flow,Disposable Patient Circuit PFNODPC-High. For use with the Precision Flow system and Ikaria INOmax DSIR ¿ System. This DPC allows clinicians to administer nitric oxide non-invasively via high flow nasal cannula. In the Precision Flow High Flow Therapy application, a special disposable patient circuit re-routes the gas to the INOmax injector module then back into the Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital, sub-acute institutions, and home settings. It adds heat and moisture to blended medical air/oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula.

    FDA Enforcement
    Class II ·Terminated·Vapotherm, Inc.·October 1, 2014

    CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016; CentriMag RVAD HDE KIT, REF: 104318; CentriMag Pre-connected Pack, REF: CMAEK00; CentriMag VAD KIT, REF: 201-51006, 201-51007, 201-90001 201-90001T; Blood Pump with CentriMag Acute Circulatory Support System for ECMO, REF: CMAEK01. CentriMag Blood Pump is a component to be used with CentriMag Acute Circulatory Support System

    FDA Enforcement
    Class II ·Ongoing·Thoratec LLC·January 21, 2026

    GE Healthcare, SIGNA 1.5T TWINSPEED, SIGNA INFINITY MRISYSTEM, SIGNA 3.0T INFINITY WITH EXCITE, SIGNA 3.0T WITH EXCITE, SIGNA EXCITE 1.5T, SIGNA EXCITE 3.0T, GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM, Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T, SIGNA Contour, Brivo MR355, Optima MR360, GE 1.5T SIGNA HDE MR SYSTEM, Signa Openspeed 0.7T MR SYSTEM, Vectra, SIGNA 0.35T OVATION WITH EXCITE, SIGNA 0.2T PROFILE With EXCITE MRI Systems

    FDA Enforcement
    Class II ·Terminated·GE Healthcare·April 1, 2015

    ExacTrac versions 6.5 through 6.5 intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, in order to treat lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. ExacTrac may also be used to monitor the patient position during the treatment.

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·March 21, 2018

    This correction applies to all GE Healthcare MRI systems with superconducting magnets: Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, GE 1.5T Signa HDe, Optima MR360, Brivo MR355, Signa Excite-HD 1.5T & 3T, Signa Excite 1.5T HD Twinspeed, Signa Excite 1.5T HD Echospeed, Signa Excite 1.5T HD Highspeed, 1.5T Signa Infinity TwinSpeed , 1.5T Signa Infinity EchoSpeed Plus, 1.5T Signa Infinity HiSpeed Plus, 1.0T Signa Infinity HiSpeed Plus. 1.0T Signa Infinity SmartSpeed, Signa EXCITE 3.0T, Signa EXCITE 3.0T HD, Signa Excite 1.5T TwinSpeed, Signa Excite 1.5T EchoSpeed, Signa Excite 1.5T HiSpeed, Signa Excite 1.5T SmartSpeed, Signa Excite 1.5T, Signa Excite 3.0T, Signa Contour/I, Signa OpenSpeed, Vectra, MR Max, Optima MR450w GEM, Discovery MR750W GEM, Optima MR450w. Product Usage: Magnetic resonance (MR) diagnostic devices are intended for producing images of the internal structures of the body based on the spatial distribution of molecules exhibiting magnetic resonance. Most MR systems are intended for diagnostic use.

    FDA Enforcement
    Class I ·Terminated·GE Healthcare·February 25, 2015