BEUDAMED
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    Syngo.via, picture archiving and communications system software controlled. Intended to be used for viewing, manipulation, communication, and storage of medical images.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 27, 2016

    Tracheal Intubation Fiberscope OLYMPUS LF-P- To be used with an Olympus Light Source, documentation equipment, display monitor and other ancillary equipment for management of Endotracheal Tube

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·August 16, 2023

    HeartStart MRx Defibrillator/Monitor M3538A Lithium Ion Batteries Revision J The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems, Inc.·March 5, 2014

    Invacare Power Wheelchair, one per box To provide mobility to a person restricted to a sitting position.

    FDA Enforcement
    Class II ·Terminated·Invacare Corporation·October 2, 2013

    GETINGE MEERA MOBILE OPERATING TABLE: (1) Part 720001B2 (2) Part 720001B0 (3) Part 720001F2 (4) Part 720001F0 (5) Part 710001B2 (6) Part 710001B0 (7) Part 710001F0 Product Usage: The Meera Mobile Operating Table is designed to support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment.

    FDA Enforcement
    Class II ·Terminated·Maquet Cardiovascular Us Sales, Llc·June 12, 2019

    IntelePACS software versions 3-8-1 to 4-9-1, Product Usage: IntelePACS is a device that receives digital images and data from various sources (such as, CT scanners, MRI scanners, ultrasound systems, R/F units, computer and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or other imaging sources.

    FDA Enforcement
    Class II ·Terminated·Intelerad Medical Systems·August 27, 2014

    Yuno Mobile Operating Table - Product Usage: Intended for support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment. Part 143301F0 (US) Part 143301B0 (OUS)

    FDA Enforcement
    Class II ·Terminated·Maquet Cardiovascular Us Sales, Llc·October 28, 2020

    Yuno II Mobile Operating Table - Product Usage: support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment. Part 143302F0 (US) Part 143302B0 (OUS)

    FDA Enforcement
    Class II ·Terminated·Maquet Cardiovascular Us Sales, Llc·October 28, 2020

    The Exacta-Mix 2400 compounding system, manufactured by Baxter Healthcare Corporation, is a compounding device used in the pharmacy to compound multiple source ingredients into one final solution. This device is not intended for direct patient hook-up.

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·August 31, 2022

    MultiDiagnostic-Eleva with Flat Detector 708035 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Nederlands·May 9, 2018

    Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring system with patient data.

    FDA Enforcement
    Class II ·Ongoing·Spacelabs Healthcare, Inc.·January 15, 2025

    Xhibit Telemetry Receiver, Model 96280, with Service Manual. Intended to provide monitoring system with patient data.

    FDA Enforcement
    Class II ·Ongoing·Spacelabs Healthcare, Inc.·January 15, 2025

    708033 URODiagnost As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Nederlands·May 9, 2018

    Widex BABY hearing aid (referred to as BABY440), powered by zinc-air batteries size 10 Intended use: BABY440 is intended for, but not limited to, babies (0 to 3 years of age) to be used as air conduction amplification devices in everyday listening environments.

    FDA Enforcement
    Class II ·Terminated·Widex A/S·October 17, 2018

    Space Pump Pole Clamps for the Infusomat Space Pump, model number 8713130. The Pole Clamp is an accessory to Space Pumps designed to support 1 to 3 pumps on a pole.

    FDA Enforcement
    Class II ·Terminated·B. Braun Medical, Inc.·January 9, 2013

    Draeger Jaundice Meter JM-105 The device is intended for use in hospitals, clinics or doctor s offices under a physician s supervision / direction to assist clinicians in monitoring of newborn infants. The device is not intended as a standalone for diagnosis of hyperbilirubinemia. It is to be used in conjunction with other clinical signs and laboratory measurements. The Jaundice Meter is not intended for home use. The Jaundice Meter may only be used at the sternum measurement site for Physician s office applications.

    FDA Enforcement
    Class I ·Terminated·Draeger Medical Systems, Inc.·June 13, 2018

    Spiegelberg Brain Pressure Monitoring System Probe 3PN, REF: SNDI3.1.531FV534P and Probe 3PS, REF: SNDI3.1.63/FV535P Product Usage: lntracranial pressure measuring probes are used to measure intracranial pressure (intracranial pressure, ICP), so the pressure in the head.

    FDA Enforcement
    Class II ·Terminated·Spiegelberg Gmbh & Co. KG·October 5, 2016

    MultiDiagnost Eleva 708036 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Nederlands·May 9, 2018

    MagNA Pure 24 System, GMMI: 07290519001 Product Usage: The MagNA Pure 24 System is a fully automated clinical sample extractor. It extracts nucleic acids from various sample types, sample tubes, and volume inputs for multiple downstream applications. The main features of the system are : Scalable purification of 1 to 24 samples Primary/secondary tube handling Inventory and sample management via barcodes Efficient order management via host The MagNA Pure 24 System offers 4 run types: Purification (rack) run Purification (cartridge) run Post Elution run Sample transfer run

    FDA Enforcement
    Class II ·Terminated·Roche Molecular Systems, Inc.·June 6, 2018

    Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation Model Number: 230000 ¿ If the recalled product is a software, include version number: firmware versions 5.0.5 or earlier

    FDA Enforcement
    Class II ·Ongoing·Breas Medical, Inc.·July 20, 2022