BEUDAMED
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    Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a component of the ROTAFLOW System Console.

    FDA Enforcement
    Class II ·Terminated·Maquet Cardiovascular Us Sales, Llc·December 18, 2019

    3T 16ch Flex SPEEDER Coil, Large, NeoCoil Part Number NC046200, Toshiba Medical Systems Model MJAJ-222A. The NeoCoil 3T 16ch Flex SPEEDER Coils are tuned to receive RF frequency corresponding to the proton precession in a 3 tesla magnetic field, which is governed by the Larmor equation. To be used in conjunction with Toshiba 3T Magnetic Resonance Scanners with ODU connectors to produce diagnostic images of the upper and lower extremities, chest, abdomen, pelvis, head, neck and spine that can be interpreted by a trained physician.

    FDA Recall
    Terminated ·NeoCoil, LLC·Product code MOS·June 17, 2016

    3T 16ch Flex SPEEDER Coil, Large, NeoCoil Part Number NC046200, Toshiba Medical Systems Model MJAJ-222A. The NeoCoil 3T 16ch Flex SPEEDER Coils are tuned to receive RF frequency corresponding to the proton precession in a 3 tesla magnetic field, which is governed by the Larmor equation. To be used in conjunction with Toshiba 3T Magnetic Resonance Scanners with ODU connectors to produce diagnostic images of the upper and lower extremities, chest, abdomen, pelvis, head, neck and spine that can be interpreted by a trained physician.

    FDA Enforcement
    Class II ·Terminated·NeoCoil, LLC·August 10, 2016

    Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a component of the ROTAFLOW System Console.

    FDA Recall
    Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code KFM·December 3, 2019

    Datex-Ohmeda S/5 Anesthesia Delivery Unit (ADU)

    FDA Recall
    Terminated ·GE Healthcare·Product code BSZ·November 16, 2005

    GE Datex-Ohmeda ADU Carestation Intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients.

    FDA Recall
    Terminated ·GE Healthcare·Product code BSZ·October 30, 2008

    Microstream SCP H PLUS O2 ADU/INT 100UN Part Number: 010625

    FDA Recall
    Terminated ·Oridion Medical·Product code cck·May 26, 2010

    Microstream SMART CAPNOLINE PLUS O2 LONG ADU/INT 25UN Part Number: 009826

    FDA Recall
    Terminated ·Oridion Medical·Product code cck·May 26, 2010

    Microstream SMART CAPNOLINE H PLUS O2 ADU/INT 25UN Part Number: 010433

    FDA Recall
    Terminated ·Oridion Medical·Product code cck·May 26, 2010

    Microstream FILTERLINE SET ADU/PED 25UN Part Number: XS04620-01 Oridion XS04661 Physio Control

    FDA Recall
    Terminated ·Oridion Medical·Product code cck·May 26, 2010

    The Azurion series (within the limits of the used Operation Room table) are intended for use to perform: "Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular and neuro procedures. "Cardiac imaging applications including diagnostics, interventional and minimally invasive surgery procedures. Additionally: "The Azurion series can be used in a hybrid Operation Room. "The Azurion series contain a number of features to support a flexible and patient centric procedural workflow.

    FDA Enforcement
    Class II ·Terminated·Philips North America Llc·September 22, 2021

    The Allura Xper series is intended for use on human patients to perform: "Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent placements, embolisations and thrombolysis. "Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA, stent placing, atherectomies), pacemaker implanatations, and electrophysiology (EP). "Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures."

    FDA Enforcement
    Class II ·Terminated·Philips North America Llc·September 22, 2021

    The Allura Xper series is intended for use on human patients to perform: "Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent placements, embolisations and thrombolysis." "Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA, stent placing, atherectomies), pacemaker implanatations, and electrophysiology (EP). Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures."

    FDA Enforcement
    Class II ·Terminated·Philips North America Llc·September 22, 2021

    Microstream SMART CAPNOLINE PLUS ADU/INT 25UN Part Number: 009818 Oridion 3012176-011 Physio Control

    FDA Recall
    Terminated ·Oridion Medical·Product code cck·May 26, 2010

    Microstream SMART CAPNOLINE PLUS O2 ADU/INT 25UN Part Number: 009822 Oridion 3012176-012 Physio Control

    FDA Recall
    Terminated ·Oridion Medical·Product code cck·May 26, 2010

    Allura Xper systems with Certeray X-ray Generator located in regions with high mains (480V) voltage. Product Usage: The Allura Xper series is intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent placements, embolisations and thrombolysis. Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA, stent placing, atherectomies), pacemaker implanatations, and electrophysiology (EP). Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures.

    FDA Enforcement
    Class II ·Terminated·Philips Electronics North America Corporation·March 7, 2018

    Allura Xper systems with Certeray X-ray Generator located in regions with high mains (480V) voltage. Product Usage: The Allura Xper series is intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent placements, embolisations and thrombolysis. Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA, stent placing, atherectomies), pacemaker implanatations, and electrophysiology (EP). Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures.

    FDA Recall
    Terminated ·Philips Electronics North America Corporation·Product code OWB·January 4, 2018

    Datex-Ohmeda AS/3 Anesthesia Delivery Unit An Anesthesia Gas Machine for composition of anesthetic breathing gas and manual or mechanical ventilation for patients undergoing anesthesia. Indicated for all persons that require inhalation anesthesia.

    FDA Recall
    Terminated ·GE Healthcare·Product code BSZ·October 30, 2008

    Datex-Ohmeda S/5 Anesthesia Delivery Unit Intended to provide general inhalation anaesthesia and ventilatory support to a wide range of patients. Intended for volume or pressure control, pressure support and synchronized intermittent mandatory (SIMV) ventilation modes.

    FDA Recall
    Terminated ·GE Healthcare·Product code BSZ·October 30, 2008

    The Allura Xper series is intended for use on human patients to perform: "Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent placements, embolisations and thrombolysis. "Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA, stent placing, atherectomies), pacemaker implanatations, and electrophysiology (EP). "Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures."

    FDA Recall
    Terminated ·Philips North America Llc·Product code OWB·August 13, 2021