BEUDAMED
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    Companion External Battery, Part Number: 293001-001 The Companion External Battery is a component of the Companion 2 Driver System and the Companion Driver System. Both Driver Systems, with the temporary Total Artificial Heart (TAH-t) are indicated for use as a bridge to transplantation in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure.

    FDA Recall
    Terminated ·SynCardia Systems Inc.·Product code DSZ·December 5, 2012

    Hemashield Finesse Ultra-thin Knitted Cardiovascular Patch.

    FDA Recall
    Terminated ·Maquet Cardiovascular, LLC·Product code DSZ·May 24, 2010

    GE Datex-Ohmeda Advance Anesthesia Gas-Machine.

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

    Mindray A5 Anesthesia Delivery System Manufactured in China for Mindray DS USA Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 This is a device used to administer to a patient continuously or intermittently a general inhalation anesthetic and to maintain a patient's ventilation.

    FDA Recall
    Terminated ·Mindray DS USA, Inc. d.b.a. Mindray North America·Product code BSZ·August 13, 2012

    Newport Portable Package, Model #50000, Serial # 13591, 13592, 13604, 13606, 13614, 13662, 13663, 13664, 13726, 13731, 13733, 13736, 13737, 13738, 13740, 13768, 13770, 13771, 13772, 13784, 13787. Product Usage: Portable Analgesia Gas Machine.

    FDA Recall
    Terminated ·Accutron Inc·Product code BSZ·April 29, 2012

    CM Flowmeter Pkg H, Model #36700, Serial # 13749 Product Usage: Conscious Sedation Unit Analgesia Gas Machine.

    FDA Recall
    Terminated ·Accutron Inc·Product code BSZ·April 29, 2012

    GE Healthcare, Avance, Avance CS2, Aisys, Aespire View, and Engstrom. Intended for volume or pressure control ventilation.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code BSZ·August 28, 2013

    McKesson Anesthesia Care Product Usage: The McKesson Anesthesia Care system is a computer based system which collects, processes,and records data both through manual entry and from monitors which themselves are attached to patients, such as in the operating room environment. The system provides clinical decision support by communicating potential Adverse Drug Event alerts proactively during the pre-anesthesia evaluation and at the point-of-care. The system is generally indicated in the anesthetizing environment when the anesthesia provider decides to perform a patient assessment, to generate a paper and/or electronic record of the administration of anesthesia to a patient, and to document care.

    FDA Recall
    Terminated ·MCKESSON TECHNOLOGIES INC.·Product code BSZ·March 15, 2013

    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

    Datex-Ohmeda S/5 Aespire Anesthesia System 7100

    FDA Recall
    Terminated ·Datex-Ohmeda Inc·Product code BSZ·September 27, 2005

    GE, 1011-9000-000 Aisys Anesthesia Machine and Monitor

    FDA Recall
    Terminated ·Ge Healthcare, Llc·Product code BSZ·March 12, 2010

    FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for use administering inhalation anesthesia on neonatal to adult patient populations.

    FDA Recall
    Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code BSZ·April 2, 2015

    GE Healthcare, Aisys, 1011-9000-000. The GE Datex-Ohmeda Aisys Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation. The Aisys is not suitable for use in a MRI environment.

    FDA Recall
    Terminated ·GE Medical Systems, LLC·Product code BSZ·December 15, 2015

    GE Healthcare, Aisys CS2,1011-9050-000; Avance Amingo,1009-9002-000, & Avance CS2, 1009-9050-000. The GE Datex-Ohmeda Aisys Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation. The Aisys is not suitable for use in a MRI environment.

    FDA Recall
    Terminated ·GE Medical Systems, LLC·Product code BSZ·December 15, 2015

    UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Catalog No. 775222 UniCel DxH Slidemaker Stainer (DxH SMS) Instructions for Use (IFU) Part Number B26647AC The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code BSZ·August 4, 2016

    A-Series A3/A5 Anesthesia Delivery System; Model Numbers: 0633F-01000-0X (A3) and 0631F-01000-0X (A5) Product Usage: The A-Series Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic, and to maintain a patient s ventilation. The A-Series is intended for use by licensed clinicians, for patients requiring anesthesia within a health care facility, and can be used for adult, pediatric, and infant populations.

    FDA Recall
    Terminated ·Mindray DS USA, Inc. dba Mindray North America·Product code BSZ·July 14, 2017

    GE Carestation 620/650/650c, A1 and A2 (non-US distribution) anesthesia systems

    FDA Recall
    Terminated ·GE Medical Systems China Co., Ltd. National Hi-Tech No.·Product code BSZ·July 24, 2018

    Fabius Trio Gas machine, anesthesia or analgesia. Catalog number 8606000. The product is used in operating rooms and ER, for patient intubation.

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code BSZ·July 7, 2008

    Fresh Gas Control (A-FGC1) Unit, a component of the S/5 Anesthesia Delivery Unit. The Anesthesia Delivery Unit is designed to mix and dose respiratory gases and to ventilate the patient. The delivery unit is the basis for a flexible anesthesia system with full monitoring and data management capabilities.

    FDA Recall
    Terminated ·GE Healthcare·Product code BSZ·March 22, 2006

    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