BEUDAMED
    12 results · 36ms · Sources: EU EUDAMED, US FDA

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    EPWorks software used in the Xltek Protektor Stimulator Product Usage: Intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.

    FDA Recall
    Terminated ·Natus Medical Incorporated 2568 Bristol Circle Oakville Canada Ontario·Product code GWF·January 2, 2015

    EPWorks software used in the Protektor 32 Product Usage: Uses electroencephalography (EEG), evoked potentials (EP), electromyography (EMG) and transcranial motor evoked potentials (TcMEP) stimulation techniques to provide healthcare professionals with information to help assess patients neurological status during surgery.

    FDA Recall
    Terminated ·Natus Medical Incorporated 2568 Bristol Circle Oakville Canada Ontario·Product code GWE·January 2, 2015

    Natus Quantum System with NeuroWorks Software. Catalog /Part Numbers: 013926. The Natus Quantum Amplifier is intended to be used as an electroencephalograph: to acquire, display, store and archive electrophysiological signals. The amplifier should be used in conjunction with Natus NeuroWorks /SleepWorks software to acquire scalp and intracranial electroencephalographic (EEG) signals as well as polysomnographic (PSG) signals.

    FDA Recall
    Terminated ·Natus Neurology DBA Excel Tech., Ltd. (XLTEK)·Product code GWQ·November 11, 2015

    Ambulatory Blood Pressure (ABP) Monitor, Model 90217A. The Spacelabs Model 90217A Ambulatory Blood Pressure (ABP) Monitor is a small, lightweight unit designed to take blood pressure and heart rate measurements for a 24 hour, 48 hour, or longer period.

    FDA Recall
    Terminated ·Del Mar Reynolds Medical, Ltd. 1-2 Harforde Ct., Foxholes Business Park Hertford United Kingdom·Product code DXN·October 12, 2011

    BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthesia gas machine. In most cases, the customer ordered both a BleaseFocus anesthesia workstation and a 700/900 ventilator. In some cases, the customer may order a 700/900 stand-alone ventilator would could be used with a BleaseFocus anesthesia workstation at a later date.

    FDA Recall
    Terminated ·Del Mar Reynolds Medical, Ltd. 1-2 Harforde Ct., Foxholes Business Park Hertford United Kingdom·Product code BSZ·November 2, 2012

    Spacelabs BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Workstation, and CAS I/II Absorber contained in Service Kits Part Number 12200902, 050-0659-00 and 050-0901-00 and any workstation installed with the CAS I/II Absorber. Anesthesia workstation for use in the hospital environment and locations not requiring portability.

    FDA Recall
    Terminated ·Del Mar Reynolds Medical, Ltd. 1-2 Harforde Ct., Foxholes Business Park Hertford United Kingdom·Product code CBK·January 15, 2013

    CAS I/II Absorbers that are parts of the BleaseSirius Anesthesia Workstation, the BleaseFocus Anesthesia Workstation with the following part numbers: 12200900; 12200901; 12200902; 12200903; 14200100, and service kits part number 050-0659-00 and 050-0901-00. BleaseFocus Anesthesia Workstation: The Blease Frontline Plus Range, Anesthesia Machines are intended for use in the hospital environment and locations not requiring portability. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of a mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. This device is intended for use only by a suitably qualified physician. BleaseSirius Anesthesia Workstation: The Spacelabs BleaseSirius Anesthesia Workstation is intended for use in the hospital environment and operating room. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. The device is intended for use only by a suitably qualified physician.

    FDA Recall
    Terminated ·Del Mar Reynolds Medical, Ltd. 1-2 Harforde Ct., Foxholes Business Park Hertford United Kingdom·Product code BSZ·October 17, 2013

    Lifescreen Apnea is Lifescreen ECG Screening System, Version 3.31. Lifescreen Apnea is indicated for screening adults for the probability that they suffer from obstructive sleep apnea, mixed apnea or hypopnea, in order to evaluate the necessity for a polysomonographic examination. The ECG recording may be obtained at any location specified by a physician including home, hospital or clinic. Subjects screened for sleep apnea should have periods of sleep of at least 4 hours duration during which the ECG is predominantly sinus rhythm in nature.

    FDA Recall
    Terminated ·Del Mar Reynolds Medical, Ltd. 1-2 Harforde Ct., Foxholes Business Park Hertford United Kingdom·Product code MNR·November 11, 2011

    SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. This system includes a ventilator.

    FDA Recall
    Terminated ·Del Mar Reynolds Medical, Ltd. 1-2 Harforde Ct., Foxholes Business Park Hertford United Kingdom·Product code CBK·March 10, 2014

    PDI Electrode Prep Pads, Skin Prep B339 are non-sterile alcohol prep pads. They are included in the Spacelabs Healthcare Hook-Up kits. Each kit contains 2-4 pieces of PDI Electrode Prep Pads . Hook-up kits that contain the affected alcohol prep pads are as follows: Aria, Kit Part number 23189-010, Kit, Basic hookup, AA; CardioCall, Kit Part number 23189-020, Kit, Hookup, CardioCall; Aria, Kit Part number 23189-106, Kit, Aria Hookup; Aria, Kit Part number 23189-110, Kit, Aria Hookup; Flashcorder, Kit Part number 23189-111, Kit, Flashcorder Hookup; Aria, Kit Part number 23189-113, Holter Hookup Kit 7 electrode; LifeCard 12, Kit Part number 23189-114, Kit, Hookup, LC12, Multilingual; Aria, Kit Part number 23189-115, Kit, Basic Hookup, AAA; LifeCard, Kit Part number 23189-116, Kit, Holter Hookup, LifeCard; 483, Kit Part number 23189-117, Kit, Holter Hookup 483; Aria, Kit Part number 23189-153, Holter Hookup Kit, 7 electrode; Aria VLC, Kit Part number 23189-207, Kit, Aria Hookup, VLC; EVO, Kit Part number 50-0048, 4 electrode hookup kit without pouch; EVO, Kit Part number 50-0049, 4 electrode hookup kit with pouch; EVO, Kit Part number SK10456, Sample Kit, Disposables. A surgical skin degreaser or an adhesive tape solvent is a device that consists of a liquid such as 1,1,2-trichloro-1,2,2-trifluoroethane; 1,1,1-trichloroethane; and 1,1,1-trichloroethane with mineral spirits intended to be used to dissolve surface skin oil or adhesive tape.

    FDA Recall
    Terminated ·Del Mar Reynolds Medical, Ltd. 1-2 Harforde Ct., Foxholes Business Park Hertford United Kingdom·Product code KOY·October 12, 2011

    Spacelabs ARKON Anesthesia Workstation. Spacelabs ARKON Anesthesia Workstation may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer.

    FDA Recall
    Terminated ·Del Mar Reynolds Medical, Ltd. 1-2 Harforde Ct., Foxholes Business Park Hertford United Kingdom·Product code CBK·June 7, 2013

    Affected device is Model 98400-SL6-AHA, CardioExpress Electrocardiograph. The ECG cable part number is 01.57.471017. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The intended use of electrocardiograph is to acquire ECG signals from adult and pediatric patients through body surface with ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. However, the interpreted ECG with measurements and interpretive statements is only intended to be used on adult patients and is offered to clinicians on an advisory basis only.

    FDA Recall
    Terminated ·Del Mar Reynolds Medical, Ltd. 1-2 Harforde Ct., Foxholes Business Park Hertford United Kingdom·Product code DPS·September 10, 2010