BEUDAMED
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    GE Datex-Ohmeda Advance Anesthesia Gas-Machine.

    FDA Recall
    Terminated ·GE Healthcare·Product code BSZ·February 5, 2009

    GE Datex-Ohmeda Aisys, Anesthesia Gas-Machine.

    FDA Recall
    Terminated ·GE Healthcare·Product code BSZ·February 5, 2009

    Carestation 620/650/650c A2 Product Usage: anesthesia systems are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (pediatric and adult.

    FDA Enforcement
    Class I ·Terminated·GE Healthcare, LLC·January 29, 2020

    Sarns Modular Perfusion System 8000 Catalog number 16414 Cardioplegia Monitor The 8K Arterial Monitor is intended for use with the 8000 Modular Perfusion System to display one average pressure and three average temperatures and also provide two digital timers. The pressure channel can have alert and alarm levels set by the user to indicate overpressure conditions. The alert and alarm level settings are retained by the system and can be recalled after the next power up. Alert and alarm conditions are indicated by flashing LED bar with single or dual audio tones; an alarm will also stop the arterial and cardioplegia pumps.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DTQ·March 21, 2012

    Carestation 620/650/650c A1 Product Usage: anesthesia systems are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (pediatric and adult.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code BSZ·November 25, 2019

    Carestation 620/650/650c A2 Product Usage: anesthesia systems are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (pediatric and adult.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code BSZ·November 25, 2019

    Sarns Modular Perfusion System 8000 Catalog number 16413 Arterial Monitor The 8K Arterial Monitor is intended for use with the 8000 Modular Perfusion System to display one average pressure and three average temperatures and also provide two digital timers. The pressure channel can have alert and alarm levels set by the user to indicate overpressure conditions. The alert and alarm level settings are retained by the system and can be recalled after the next power up. Alert and alarm conditions are indicated by flashing LED bar with single or dual audio tones; an alarm will also stop the arterial and cardioplegia pumps.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DTQ·March 21, 2012

    Sarns Modular Perfusion System 8000 Catalog number 148689 or 78-8067-3878-3 Temperature-Pressure Board, Cardioplegia Monitor (service part only) The 8K Arterial Monitor is intended for use with the 8000 Modular Perfusion System to display one average pressure and three average temperatures and also provide two digital timers. The pressure channel can have alert and alarm levels set by the user to indicate overpressure conditions. The alert and alarm level settings are retained by the system and can be recalled after the next power up. Alert and alarm conditions are indicated by flashing LED bar with single or dual audio tones; an alarm will also stop the arterial and cardioplegia pumps.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DTQ·March 21, 2012

    Sarns Modular Perfusion System 8000 Catalog number 149112 or 78-8067-4840-2 Temperature-Pressure Board, Arterial Monitor (service part only) The 8K Arterial Monitor is intended for use with the 8000 Modular Perfusion System to display one average pressure and three average temperatures and also provide two digital timers. The pressure channel can have alert and alarm levels set by the user to indicate overpressure conditions. The alert and alarm level settings are retained by the system and can be recalled after the next power up. Alert and alarm conditions are indicated by flashing LED bar with single or dual audio tones; an alarm will also stop the arterial and cardioplegia pumps.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DTQ·March 21, 2012

    Pathfinder Holter Analyzer is a Programmable Diagnostic Computer. The brochure is labeled in part: "***Pathfinder Holter Analyzer ***Spacelabs Healthcare Company Headquarters***5150 220th Ave. SE, Issaquah, WA 98029***PO Box 7018, Issaquah, WA 98027-7018***Telephone: 425-657-7200***In North America: 800-522-7025***www.spacelabshealthcare.com***". The Reynolds Pathfinder 700 Holter Analyzer is intended to be used to analyze magnetic tapes of ambulatory electrocardiograms made on compatible Holter Recorders. The system will detect various arrhythmias and will measure ST elevation or depression. The system acts in both a automatic mode (tape analyzed without operator intervention) and in an interactive mode; (operator can intervene and affect analysis).

    FDA Recall
    Terminated ·Spacelabs Healthcare, Llc·Product code DQK·May 24, 2011

    Philips V60 Ventilator with Version 2.20 Software, Description: V 60 Ventilator,Intl Opt: CFLEX,AVAPS,PPV V60 Ventilator,Intl Opt: CFLEX,AVAPS V60 Ventilator,Intl Opt: None V60 Ventilator,English Opt: None V60 Ventilator,Engl Opt: CFLEX,AVAPS V60 Us Demo Unit V60 USED ENGL OPT:CFLEX, AVAPS,PPV,AT+cl V60 VENT, JAPAN OPT: CFLEX, AVAPS, AT+ V60 VENT, JAPAN OPT: CFLEX, AVAPS, AT+ Catalog/REF No. 1053613, 1053614, 1053615, 1053616, 1053617, DU1053617, U1053617, 1076709, R1076709

    FDA Recall
    Terminated ·Respironics California Inc·Product code MNT·February 1, 2017

    Carestation 620/650/650c A1 Product Usage: anesthesia systems are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (pediatric and adult.

    FDA Enforcement
    Class I ·Terminated·GE Healthcare, LLC·January 29, 2020

    G3 Opticage Expandable Interbody Fusion Device, Model No. 9180-00, 9180-01, 9180-06, 9180-07, 9180-17, 9101-00, 9101-06 The Opticage Expandable Interbody Fusion Device is a posterior lumbar intervertebral body fusion device and is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Opticage Interbody Fusion Device can be implanted via posterior, transforaminal or lateral approach. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Candidates for surgery should be skeletally mature and have had six months of conservative treatment. These patients may have had primary or secondary surgery, but no previous fusion at the involved levels. The device is not intended to be used as a stand-alone device. It must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine (i.e. facet screw fixation systems, facet compression devices and posterior pedicle screw and rod systems).

    FDA Enforcement
    Class II ·Terminated·Interventional Spine Inc·January 11, 2017

    Celsite Implantable Access Port System, model ST301. The Celsite Implantable Access Port Systems (Celsite port systems) are implantable port and catheter systems that allow safe, repeated access to the patient's bloodstream. The port chamber and catheter design can be used for the administration of medication and fluids. The Celsite system consists of an access port with a silicone septum, which is connected to a catheter using a connection ring. The triangular shaped access port has a low profile nose, finger stops on the side of the housing, and a round base. Celsite access ports have suture holes or suture zones to secure placement during implantation.

    FDA Enforcement
    Class II ·Terminated·B. Braun Interventional Systems·August 19, 2015

    SurgAssist System Circular Stapler DLU 33mm

    FDA Recall
    Terminated ·Power Medical Interventions·Product code GWD·November 20, 2003

    PERPOS PLS, CATALOG #'s 9045-01 & 9045-02 A sterile, medical device kit consisting of the components listed in Table 1-1 below. The kit is used by medical professionals to stabilize the spine as an aid to fusion through immobilization of the facet joints.

    FDA Recall
    Terminated ·Interventional Spine Inc·Product code MRW·March 15, 2011

    Catalog # 9024-00 or LSW-S-3040 for 4.5mm BONE-LOK PLS Implant A sterile, canulated screw that is supplied as a stand-alone product. The 4.5mm BONE-LOK PLS Implant is also supplied as a component of the Single Use PERPOS PLS System (9045-01 and 9045-02). The labeling and instructions for use for the 4.5mm BONE-LOK PLS a Implant (9024-00) are provided in Appendix C.

    FDA Recall
    Terminated ·Interventional Spine Inc·Product code MRW·March 15, 2011

    SurgAssist System Circular Stapler DLU 29mm

    FDA Recall
    Terminated ·Power Medical Interventions·Product code GWD·November 20, 2003

    SurgASSIST System. Circular Stapler DLU 33 mm (product code CS33).

    FDA Recall
    Terminated ·Power Medical Interventions·Product code GAG·June 30, 2003

    G3 Opticage Expandable Interbody Fusion Device, Model No. 9180-00, 9180-01, 9180-06, 9180-07, 9180-17, 9101-00, 9101-06 The Opticage Expandable Interbody Fusion Device is a posterior lumbar intervertebral body fusion device and is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Opticage Interbody Fusion Device can be implanted via posterior, transforaminal or lateral approach. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Candidates for surgery should be skeletally mature and have had six months of conservative treatment. These patients may have had primary or secondary surgery, but no previous fusion at the involved levels. The device is not intended to be used as a stand-alone device. It must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine (i.e. facet screw fixation systems, facet compression devices and posterior pedicle screw and rod systems).

    FDA Recall
    Terminated ·Interventional Spine Inc·Product code MAX·November 22, 2016