BEUDAMED
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    Raindrop Near Vision Inlay, REF: RD1-1, Sterile, Rx Only, Manufacturer ReVision Optics, Inc.

    FDA Recall
    Terminated ·RVO 2.0, INC·Product code LQE·November 13, 2018

    GE Healthcare Revolution EVO, Optima CT660, Optima CT670, Optima CT680. The systems are intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. Sold under the following product names: CT GOLDSEAL LIGHTSPEED ULTRA, CT OPTIMA 660, CT OPTIMA 660 M40 3.5 LONG BJG, CT OPTIMA 660 M40 GT1700, CT OPTIMA 660 M40 GT1700 BEIJI, CT OPTIMA 660 M40 GT1700 HINO, CT OPTIMA 660 M40 GT2000 BEIJI, CT OPTIMA 660 M40 GT2000 HINO, CT OPTIMA CT 660, CT OPTIMA CT660, CT OPTIMA CT660 M4, CT OPTIMA CT660 M40, CT REVOLUTION EVO 3.5 LONG HIN, CT REVOLUTION EVO VT2000 HINO, CT660 MAR UPGRADE, MOBILE OPTIMA CT 660, OPTI660_A_G_2.0, OPTI660_M40_G, OPTI660_M40_L, OPTIMA 660, OPTIMA 660 128 FOR TW- DIRECT, OPTIMA 660 GT2000 M40 HINO MULTISLICE, OPTIMA 660 M40, OPTIMA 660 M40, OPTIMA 660 M40 3.5 HVY BJG, OPTIMA 660 M40 3.5 LONG BJG, OPTIMA 660 M40 3.5 LONG BJG, OPTIMA 660 M40 3.5 LONG HINO, OPTIMA 660 M40 3.5 MID, OPTIMA 660 M40 3.5 MID BJG, OPTIMA 660 M40 3.5 MID HINO, OPTIMA 660 M40 3.5/6, OPTIMA 660 M40 3.5/6 HVY BJG, OPTIMA 660 M40 3.5/6 HVY HINO, OPTIMA 660 M40 3.5/6 HVY WAUK, OPTIMA 660 M40 3.5/6 LONG, OPTIMA 660 M40 3.5/6 LONG B, OPTIMA 660 M40 3.5/6 LONG BJG, OPTIMA 660 M40 3.5/6 LONG HINO, OPTIMA 660 M40 3.5/6 LONG WAUK, OPTIMA 660 M40 3.5/6 MID BJ, OPTIMA 660 M40 3.5/6 MID BJG, OPTIMA 660 M40 3.5/6 MID HI, OPTIMA 660 M40 3.5/6 MID HINO, OPTIMA 660 M40 3.5/6 MID WA, OPTIMA 660 M40 3.5/6 MID WAUK, OPTIMA 660 M40 GT1700, OPTIMA 660 M40 GT1700 BEIJING, OPTIMA 660 M40 GT1700 HINO, OPTIMA 660 M40 GT1700 WAUK, OPTIMA 660 M40 GT2000 B, OPTIMA 660 M40 GT2000 BEIJI, OPTIMA 660 M40 GT2000 BEIJING, OPTIMA 660 M40 GT2000 HINO, OPTIMA 660 M40 GT2000 WAUK, OPTIMA 660 M40 MOBILE BEIJING, OPTIMA CT 660, OPTIMA CT660 ASIR, OPTIMA CT660 ASIR 128 M RU, OPTIMA CT660 FREEDOM MD HN2, OPTIMA CT660 M40 GT1700, OPTIMA CT660 M40 GT2000, OPTIMA CT660 M40 GT2000 BEIJIN, OPTIMA CT660 M40 GT2000 HINO, OPTIMA CT660 P2.5, OPTIMA CT660 P25 UPG KIT, OPTIMA CT660 PRO MID, OPTIMA CT660 SE, OPTIMA CT660 SE GT 1700, OPTIMA CT680, OPTIMA CT680 KL64 GT1700 BHW, REVOLUTION EVO, REVOLUTION EVO 3.5 HVY BJG, REVOLUTION EVO 3.5 HVY HINO, REVOLUTION EVO 3.5 HVY WAUK, REVOLUTION EVO 3.5 LONG BJG, REVOLUTION EVO 3.5 LONG HINO, REVOLUTION EVO 3.5 LONG WAUK, REVOLUTION EVO 3.5 MID BJG, REVOLUTION EVO 3.5 MID HINO, REVOLUTION EVO 3.5 MID WAUK, REVOLUTION EVO 3.5MID HINO CT, REVOLUTION EVO 3.6 CHN HINO, REVOLUTION EVO 3.6 HVY BJG, REVOLUTION EVO 3.6 HVY HINO, REVOLUTION EVO 3.6 HVY WAUK, REVOLUTION EVO 3.6 LONG, REVOLUTION EVO 3.6 LONG BJG, REVOLUTION EVO 3.6 LONG HIN, REVOLUTION EVO 3.6 LONG HINO, REVOLUTION EVO 3.6 LONG WAUK, REVOLUTION EVO 3.6 MID BJG, REVOLUTION EVO 3.6 MID HINO, REVOLUTION EVO 3.6 MID WAUK, REVOLUTION EVO 3.6B, REVOLUTION EVO 3.6B HVY HINO, REVOLUTION EVO 3.6B LONG, REVOLUTION EVO 3.6B LONG BJG, REVOLUTION EVO 3.6B LONG HINO, REVOLUTION EVO 3.6B MID BJG, REVOLUTION EVO 3.6B MID HINO, REVOLUTION EVO GT1700, REVOLUTION EVO GT2000, REVOLUTION EVO GT2000 HINO, REVOLUTION EVO GT2000X (HINO), REVOLUTION EVO GT2000X HINO, REVOLUTION EVO VT1700 BEIJING, REVOLUTION EVO VT1700 HINO, REVOLUTION EVO VT1700 WAUK, REVOLUTION EVO VT2000 BEIJING, REVOLUTION EVO VT2000 HINO, REVOLUTION EVO VT2000 WAUK, REVOLUTION EVO VT2000X BEIJING, REVOLUTION EVO VT2000X HINO, REVOLUTION EVO VT2000X WAUK, REVOLUTION EVO WITH GT1700V TA, REVOLUTION EVO WITH GT2000 TAB

    FDA Recall
    Terminated ·GE Healthcare Japan Corporation Ge Herusukea.Japan Kabu 4 Chome 7-127 Asahigaoka Hino Japan·Product code JAK·April 27, 2018

    Raindrop Near Vision Inlay, REF: RD1-1, Sterile, Rx Only, Manufacturer ReVision Optics, Inc.

    FDA Enforcement
    Class I ·Terminated·RVO 2.0, INC·March 13, 2019

    Trilogy EVO Ventilator, 02 - International - Model Number: IN2100X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories.

    FDA Recall
    Terminated ·Philips Respironics, Inc.·Product code CBK·November 19, 2019

    Trilogy EVO Ventilator, Great Britain - Model Number: GB2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories.

    FDA Recall
    Terminated ·Philips Respironics, Inc.·Product code CBK·November 19, 2019

    Trilogy EVO Ventilator, Germany - Model Number: DE2110X13B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories.

    FDA Recall
    Terminated ·Philips Respironics, Inc.·Product code CBK·November 19, 2019

    Trilogy EVO Ventilator, 02 - Iberia - Model Number: ES2100X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories.

    FDA Recall
    Terminated ·Philips Respironics, Inc.·Product code CBK·November 19, 2019

    Trilogy EVO Ventilator, 02 - Italy - Model Number: IT2100X21B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories.

    FDA Recall
    Terminated ·Philips Respironics, Inc.·Product code CBK·November 19, 2019

    LifeVent EVO Ventilator, 02 - Model Number: SP2100X26B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories.

    FDA Recall
    Terminated ·Philips Respironics, Inc.·Product code CBK·November 19, 2019

    Trilogy EVO Ventilator, France - Model Number: FR2110X14B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories.

    FDA Recall
    Terminated ·Philips Respironics, Inc.·Product code CBK·November 19, 2019

    Garbin EVO Ventilator, Linde - Model Number: LD2110X23B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories.

    FDA Recall
    Terminated ·Philips Respironics, Inc.·Product code CBK·November 19, 2019

    Trilogy EVO Ventilator, Iberia - Model Number: ES2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories.

    FDA Recall
    Terminated ·Philips Respironics, Inc.·Product code CBK·November 19, 2019

    Trilogy EVO Ventilator, Nordics - Model Number: ND2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories.

    FDA Recall
    Terminated ·Philips Respironics, Inc.·Product code CBK·November 19, 2019

    Trilogy EVO Ventilator, 02 - EU - Model Number: EU2100X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories.

    FDA Recall
    Terminated ·Philips Respironics, Inc.·Product code CBK·November 19, 2019

    Trilogy EVO Ventilator, International, Model Number IN2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories.

    FDA Recall
    Terminated ·Philips Respironics, Inc.·Product code CBK·November 19, 2019

    Trilogy EVO Ventilator, EU - Model Number: EU2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories.

    FDA Recall
    Terminated ·Philips Respironics, Inc.·Product code CBK·November 19, 2019

    HexaPOD evo RT Couch Top (also known as HexaPOD evo Module), a component of the HexaPOD evo RT system. Product Usage: To support and aid in positioning a patient during radiation therapy

    FDA Recall
    Terminated ·Elekta, Inc.·Product code JAI·May 16, 2018

    Tecan Freedom EVO with Touch Tools Suite Version 3.0 The intended use of the Touch Tools Suite is to run previously defined scripts and processes on a Freedom EVO platform (Touch Tools Suite is an optional software add-on for Freedom EVOware (the base operational software for the Freedom EVO 2 instrument.

    FDA Enforcement
    Class II ·Terminated·Tecan US, Inc.·June 26, 2013

    GE Healthcare Revolution EVO, Optima CT660, Optima CT670, Optima CT680. The systems are intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. Sold under the following product names: CT GOLDSEAL LIGHTSPEED ULTRA, CT OPTIMA 660, CT OPTIMA 660 M40 3.5 LONG BJG, CT OPTIMA 660 M40 GT1700, CT OPTIMA 660 M40 GT1700 BEIJI, CT OPTIMA 660 M40 GT1700 HINO, CT OPTIMA 660 M40 GT2000 BEIJI, CT OPTIMA 660 M40 GT2000 HINO, CT OPTIMA CT 660, CT OPTIMA CT660, CT OPTIMA CT660 M4, CT OPTIMA CT660 M40, CT REVOLUTION EVO 3.5 LONG HIN, CT REVOLUTION EVO VT2000 HINO, CT660 MAR UPGRADE, MOBILE OPTIMA CT 660, OPTI660_A_G_2.0, OPTI660_M40_G, OPTI660_M40_L, OPTIMA 660, OPTIMA 660 128 FOR TW- DIRECT, OPTIMA 660 GT2000 M40 HINO MULTISLICE, OPTIMA 660 M40, OPTIMA 660 M40, OPTIMA 660 M40 3.5 HVY BJG, OPTIMA 660 M40 3.5 LONG BJG, OPTIMA 660 M40 3.5 LONG BJG, OPTIMA 660 M40 3.5 LONG HINO, OPTIMA 660 M40 3.5 MID, OPTIMA 660 M40 3.5 MID BJG, OPTIMA 660 M40 3.5 MID HINO, OPTIMA 660 M40 3.5/6, OPTIMA 660 M40 3.5/6 HVY BJG, OPTIMA 660 M40 3.5/6 HVY HINO, OPTIMA 660 M40 3.5/6 HVY WAUK, OPTIMA 660 M40 3.5/6 LONG, OPTIMA 660 M40 3.5/6 LONG B, OPTIMA 660 M40 3.5/6 LONG BJG, OPTIMA 660 M40 3.5/6 LONG HINO, OPTIMA 660 M40 3.5/6 LONG WAUK, OPTIMA 660 M40 3.5/6 MID BJ, OPTIMA 660 M40 3.5/6 MID BJG, OPTIMA 660 M40 3.5/6 MID HI, OPTIMA 660 M40 3.5/6 MID HINO, OPTIMA 660 M40 3.5/6 MID WA, OPTIMA 660 M40 3.5/6 MID WAUK, OPTIMA 660 M40 GT1700, OPTIMA 660 M40 GT1700 BEIJING, OPTIMA 660 M40 GT1700 HINO, OPTIMA 660 M40 GT1700 WAUK, OPTIMA 660 M40 GT2000 B, OPTIMA 660 M40 GT2000 BEIJI, OPTIMA 660 M40 GT2000 BEIJING, OPTIMA 660 M40 GT2000 HINO, OPTIMA 660 M40 GT2000 WAUK, OPTIMA 660 M40 MOBILE BEIJING, OPTIMA CT 660, OPTIMA CT660 ASIR, OPTIMA CT660 ASIR 128 M RU, OPTIMA CT660 FREEDOM MD HN2, OPTIMA CT660 M40 GT1700, OPTIMA CT660 M40 GT2000, OPTIMA CT660 M40 GT2000 BEIJIN, OPTIMA CT660 M40 GT2000 HINO, OPTIMA CT660 P2.5, OPTIMA CT660 P25 UPG KIT, OPTIMA CT660 PRO MID, OPTIMA CT660 SE, OPTIMA CT660 SE GT 1700, OPTIMA CT680, OPTIMA CT680 KL64 GT1700 BHW, REVOLUTION EVO, REVOLUTION EVO 3.5 HVY BJG, REVOLUTION EVO 3.5 HVY HINO, REVOLUTION EVO 3.5 HVY WAUK, REVOLUTION EVO 3.5 LONG BJG, REVOLUTION EVO 3.5 LONG HINO, REVOLUTION EVO 3.5 LONG WAUK, REVOLUTION EVO 3.5 MID BJG, REVOLUTION EVO 3.5 MID HINO, REVOLUTION EVO 3.5 MID WAUK, REVOLUTION EVO 3.5MID HINO CT, REVOLUTION EVO 3.6 CHN HINO, REVOLUTION EVO 3.6 HVY BJG, REVOLUTION EVO 3.6 HVY HINO, REVOLUTION EVO 3.6 HVY WAUK, REVOLUTION EVO 3.6 LONG, REVOLUTION EVO 3.6 LONG BJG, REVOLUTION EVO 3.6 LONG HIN, REVOLUTION EVO 3.6 LONG HINO, REVOLUTION EVO 3.6 LONG WAUK, REVOLUTION EVO 3.6 MID BJG, REVOLUTION EVO 3.6 MID HINO, REVOLUTION EVO 3.6 MID WAUK, REVOLUTION EVO 3.6B, REVOLUTION EVO 3.6B HVY HINO, REVOLUTION EVO 3.6B LONG, REVOLUTION EVO 3.6B LONG BJG, REVOLUTION EVO 3.6B LONG HINO, REVOLUTION EVO 3.6B MID BJG, REVOLUTION EVO 3.6B MID HINO, REVOLUTION EVO GT1700, REVOLUTION EVO GT2000, REVOLUTION EVO GT2000 HINO, REVOLUTION EVO GT2000X (HINO), REVOLUTION EVO GT2000X HINO, REVOLUTION EVO VT1700 BEIJING, REVOLUTION EVO VT1700 HINO, REVOLUTION EVO VT1700 WAUK, REVOLUTION EVO VT2000 BEIJING, REVOLUTION EVO VT2000 HINO, REVOLUTION EVO VT2000 WAUK, REVOLUTION EVO VT2000X BEIJING, REVOLUTION EVO VT2000X HINO, REVOLUTION EVO VT2000X WAUK, REVOLUTION EVO WITH GT1700V TA, REVOLUTION EVO WITH GT2000 TAB

    FDA Enforcement
    Class II ·Terminated·GE Healthcare Japan Corporation·August 29, 2018

    EVO Excel, Emission Computed Tomographic System, Material Number 10910501

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code KPS·October 5, 2018