BEUDAMED
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    Continuous ventilator accessories under the following brand names: a) RP-Seal, Spring-5 pk model number F35465; b) RP-Seal, Greece, Ballscrew model number F35036; c) RP-Tub PVC 1/8 in x 50 ft model number 1008841; d) RP-Vision Filter Cover model number 1003444; e) RP-Vision RS-232 HRN ABV 106K model number 1004699; and f) RP-Wrap, Cord model number F35195. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.

    FDA Recall
    Terminated ·Respironics, Inc.·Product code CBK·October 15, 2007

    Presage ST2 Assay, catalog numbers BC-1065 and BC-1065E. The Critical Diagnostics Presage ST2 Assay kit is an in vitro diagnostic device that quantitatively measures ST2 in serum or plasma by enzyme-linked immunosorbent assay (ELISA) in a microtiter plate format. The Presage ST2 Assay is indicated to be used in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure.

    FDA Enforcement
    Class III ·Terminated·Critical Diagnostics·July 25, 2012

    Century Console Base, Model #043625051b. Intended for use as a platform for other ancillary equipment and disposable products in cardiopulmonary surgical procedures.

    FDA Enforcement
    Class II ·Terminated·Salyer Prn Biomedical·March 13, 2013

    Century Console Base, Model #043625051b. Intended for use as a platform for other ancillary equipment and disposable products in cardiopulmonary surgical procedures.

    FDA Recall
    Terminated ·Salyer Prn Biomedical·Product code DTQ·January 31, 2013

    Pausch Uroview FD fluoroscopic X-ray system UDI number (01)04260491620040 Primarily for urological applications (functional X-ray diagnostics, endourology and minimal invasive urology / surgery). The system, which includes a radiologic / urologic treatment table, maybe used for urological treatment, planning and diagnostic procedures, including but not limited to.

    FDA Enforcement
    Class II ·Terminated·Hans Pausch Rontgengeratebau Gmbh·June 7, 2017

    RotoRest Delta Advanced Therapy System. The RotoRest Delta Advanced Kinetic Therapy System offers kinetic therapy for the most aggressive treatment of pulmonary complications.

    FDA Recall
    Terminated ·Arjo Hospital Equipment AB HANS MICHELSENSGATAN·Product code IKZ·December 3, 2014

    Pressure IQ Evolve Mattress; Non-powered mattress replacement system. Intended for patients with medium to high risk for developing pressure ulcers while on a mattress.

    FDA Recall
    Terminated ·Arjo Hospital Equipment AB HANS MICHELSENSGATAN·Product code IKY·September 1, 2014

    Rotoprone Therapy System. The Rotoprone Therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications.

    FDA Recall
    Terminated ·Arjo Hospital Equipment AB HANS MICHELSENSGATAN·Product code IKZ·December 3, 2014

    TriaDyne Proventa Critical Care Therapy System. The TriaDyne Proventa Critical Care Therapy System provides a comprehensive system of pulmonary and skin care therapies for the critically ill, immobilized patient.

    FDA Recall
    Terminated ·Arjo Hospital Equipment AB HANS MICHELSENSGATAN·Product code IKZ·December 3, 2014

    Replacement leadwires with grabber ends: REF/Catalog Number Description 2106388-005 Replacement ECG Leadwire, grabber, BRN V, AHA, 74 cm/ 29 in 2106388-101 Replacement ECG Leadwire, grabber, LL , AHA, 130 cm/ 51 in 2106388-103 Replacement ECG Leadwire, grabber, GRN RL, AHA, 130 cm/ 2106388-107 Replacement ECG Leadwire, grabber, BLK N, IEC, 130 cm/ 51 in 2106392-004 Replacement ECG Leadwire, grabber, ORG V, AHA, 74 cm/ 29 in The reusable ECG leadwire sets enable ECG monitoring with GE equipment requiring rectangular 11-pin ECG trunk cable. Use leadwire sets with ECG trunk cable or telemetry transmitter.

    FDA Enforcement
    Class III ·Terminated·GE Healthcare, LLC·July 3, 2019

    Pausch Uroview FD fluoroscopic X-ray system UDI number (01)04260491620040 Primarily for urological applications (functional X-ray diagnostics, endourology and minimal invasive urology / surgery). The system, which includes a radiologic / urologic treatment table, maybe used for urological treatment, planning and diagnostic procedures, including but not limited to.

    FDA Recall
    Terminated ·Hans Pausch Rontgengeratebau Gmbh Graf Zeppelin Strasse 1 Erlangen Germany·Product code JAA·March 14, 2017

    NeuViz Dual series computed Tomography Scanner System, X-Ray System The CT scanner is a whole body x-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle.

    FDA Recall
    Terminated ·Philips And Neusoft Medical Systems Co., Ltd. Neusoft Park, Hun Nan Industrial Area Shenyang, Liaoning China·Product code JAK·December 17, 2007

    The device is the NeuViz Dual series Computed Tomography (CT) Scanner System. The device is identified as NeuViz Dual, PN: 989605651321. Labeling on the device reads in part: "***Neusoft NeuViz Dual MULTI-SLICE CT SCANNER SYSTEM***MANUFACTURED BY PHILIPS AND NEUSOFT MEDICAL SYSTEMS CO., LTD. ADDRESS: NEUSOFT PARK, HUN NAN INDUSTRIAL AREA, SHENYANG 110179, CHINA***". Device is intended to produce cross-section images of head and body by computer reconstruction of x-ray transmission data taken at different angles.

    FDA Recall
    Terminated ·Philips And Neusoft Medical Systems Co., Ltd. Neusoft Park, Hun Nan Industrial Area Shenyang, Liaoning China·Product code JAK·February 10, 2010

    Baxter 6060 Multi-Therapy Infusion Pump, product code 2M9832; Manufactured by an affiliate of Baxter Healthcare Corp., Deerfield, IL 60013 USA, made in Singapore

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt·Product code FRN--·December 17, 2003

    Smiths Medical CADD-Sentry Pro Medication Safety Software - electronic pump protocol programming software - Administrator REF 21-6275-51 RX only, Smiths Medical MD, Inc. St Paul, Minnesota 55112 USA

    FDA Recall
    Terminated ·Smiths Medical MD, Inc.·Product code FRN·August 14, 2007

    Plum A+ Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 11971 b) list 11973 - software version 10.3 c) list 12391 - software version 11.3 d) list 20679 - Hospira MedNet Software e) list 20792 - Driver The Plum A+ dual-line volumetric infusion system designed to meet the growing demand for hospital-wide, as well as alternate site and home healthcare, standardization. With their primary line, secondary line, and piggyback fluid delivery capability, the Plum A+ is suited for a wide range of medical/surgical and critical care applications. Full compatibility with LifeCare Plum Series administration sets and accessories and the LifeShield needleless protection systems makes the Plum A+ a convenient and cost-effective infusion system.

    FDA Recall
    Terminated ·Hospira Inc.·Product code FRN·September 16, 2011

    ***This recall is being conducted due to an incomplete recall for RES 57829*** Curlin Infusion Administration Set, REF 340-4165, Sterile EO, The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications.

    FDA Recall
    Terminated ·MOOG Medical Devices Group·Product code FRN·September 26, 2012

    SIGMA SPECTRUM Infusion Pump with Master Drug Library. Intended to be used for the controlled administration of intravenous fluids.

    FDA Recall
    Terminated ·Baxter Healthcare Corp.·Product code FRN·June 10, 2013

    GemStar Docking Station, used with GemStar infusion pump, in combination with other GemStar accessories such as the GemStar Lock Box and patient bolus cord. The docking station is also used for hosting the GemStar pump for general infusions. List Numbers: 13075-XX-XX.

    FDA Recall
    Terminated ·Hospira Inc.·Product code FRN·February 18, 2014

    Plum XL3 Multi line Infusion System, Micro Macro Plum XL3 Multi line Infusion System, and Micro Macro Plum XL Infusion System. Infusion pumps for intravenous. arterial, short-term epidural, and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products to patients in hospital and home care environments.

    FDA Recall
    Terminated ·Hospira Inc.·Product code FRN·January 24, 2014