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    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

    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

    EVO Excel, Emission Computed Tomographic System, Material Number 10910501

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

    smith&nephew, 2.4 MM, 6 HOLE, EVOS, FLEX PLATE, SST Plate, REF CATALOG NUMBER 72442360N, NON-STERILE, Rx only, (01)00885556456446(10), (11)171116 Bone plates and bone screws from the EVOS Mini-Fragment Plating System are intended for use in internal fixation of small bones and small bone fragments and non-load bearing stabilization and reduction of bone fragments in long bones.

    FDA Recall
    Terminated ·Smith & Nephew, Inc.·Product code HRS·November 29, 2017

    Knee Components: ROTULE "913" D=32 , Part Number PGA00030, Lot Number X02383380 INSERT TIBIAL "913 PCR" T.1 - EP.10-, PGA00050, Lot Numbers: V11272719, W02300988, W09372781, W09372781, and W10372876 INSERT TIBIAL "913 PCR" T.1 - EP.14-, PGA00054, Lot Number: V0266952 INSERT TIBIAL "913 PCR" T.2 - EP.10-, PGA00080, Lot Numbers: X02396582, X05401377, and W01287345 INSERT TIBIAL "913 PCR" T.3 - EP.10-, PGA00110, Lot Numbers: W09359102, X03396584, and W1166335 INSERT TIBIAL "913 PCR" T.5 - EP.14-, PGA00174, Lot Number: W0675535 PLATEAU TIBIAL "913" T.4 MOINS , PGA00216, Lot Number: X10391238 PLATEAU TIBIAL "913" T.5 MOINS , PGA00218, Lot Numbers: V0379902 and V0381596 PLATEAU TIBIAL "913" T.1 , PGA00230, Lot Numbers: W05327837 and W0779903 PLATEAU TIBIAL "913" T.2 PLUS , PGA00252, Lot Number: X06391241 TIGE INTRAMEDULLAIRE "913" D=16 L=75, PGA00716, Lot Number: X02382967 TIGE INTRAMEDULLAIRE "913" D=12 L=125, PGA00752, Lot Number: W06322599 TIGE INTRAMEDULLAIRE "913" D=14 L=125, PGA00754, Lot Number: V12272733 TIGE INTRAMEDULLAIRE "913" D=16 L=125, PGA00756, Lot Number: V12272734 TIGE INTRAMEDULLAIRE "913" D=18 L=125, PGA00758, Lot Number: W04336344 TIGE DE REPRISE FEMO/TIB. "913" D=14 L=75, PGA00814, Lot Number: V0767876 TIGE DE REPRISE FEMO/TIB. "913" D=16 L=75, PGA00816, Lot Number: V0767877 CALE TIBIALE "913" T.1 -EP.8- , PGA00950, Lot Number: W0380839 CALE TIBIALE "913" T.2 -EP.8- , PGA00952, Lot Number: V0773498 and V0973301 INSERT TIBIAL "913 RS" T.1 - EP.10-, PGA14010, Lot Number: V0782533 INSERT TIBIAL "913 RS" T.1 - EP.12-, PGA14012, Lot Number: V0766107 and V0782536 INSERT TIBIAL "913 RS" T.1 - EP.16-, PGA14016, V0782531 INSERT TIBIAL "913 RS" T.5 - EP.12-, PGA14044, Lot Number V0782542 INSERT TIBIAL "913 RS" T.5 - EP.14-, PGA14046, Lot Number: V0782540 INSERT TIBIAL "913 MP" T.1 GAUCHE -EP.17-, PGA14508, Lot Number: V05210017 PATELLA TRI-PEG "FPV EVOS" RIGHT SIZE 38, PGA20016, Lot Numbers: X03397144, X04401212, X05401380, X05418562, and X05419556 PATELLA TRI-PEG "FPV EVOS" RIGHT SIZE 41, PGA20018, Lot Numbers: X03397145, X04400214, X04401213, X05401381, and X05418563 PATELLA TRI-PEG "FPV EVOS" LEFT SIZE 35, PGA20024, Lot Number: X07429260 PATELLA TRI-PEG "FPV EVOS" LEFT SIZE 38, PGA20026, Lot Numbers: X03397148, X04400217, X04401217, X05401384, and X05418557 PATELLA TRI-PEG "FPV EVOS" LEFT SIZE 41, PGA20028, Lot Numbers: X03397149, X04400218, X04401218, X05401385, and X05418559 TROCHLEA "FPV EVOS" RIGHT SIZE 3, PGA20116, Lot Number: X05427577 TROCHLEA "FPV EVOS" RIGHT SIZE 4, PGA20118, Lot Numbers: X03397138, X05427571, X05427578, and X07428738 TROCHLEA "FPV EVOS" LEFT SIZE 3, PGA20126, Lot Numbers: X05427573 and X05427582 TROCHLEA "FPV EVOS" LEFT SIZE 4, PGA20128, Lot Numbers: X03397141, X05427567, X05427574, X05427583, X0542758310, and X07427587 PLAT. TIBIAL TITANE IB II-59 S/CIMENT EQUIPE, PPB21002, Lot Number: W11373017 PLAT. TIBIAL TITANE IB II-69 S/CIMENT EQUIPE, PPB21006, Lot Number: W01278824 PLAT. TIBIAL TITANE IB II-74 S/CIMENT EQUIPE, PPB21008, Lot Numbers: V0281306 and V1128727 2 VIS POUR PLATEAU TIBIAL S/C IB II:D=5.5*20 (TITANE), PPB22000, Lot Number: X04418520 PLAT. TIBIAL TITANE IB II-54 A/CIMENT EQUIPE, PPB30030, Lot Number: W09359212 PLAT. TIBIAL TITANE IB II-59 A/CIMENT EQUIPE, PPB30034, Lot Number: W11373000 PLATEAU TIBIAL PE IB II-64 8.5, PPB30140, Lot Numbers: V12278842, W01301110, W03308823, W05327953, W07350813, and W09359226 PLATEAU TIBIAL PE IB II-64 10, PPB30142, Lot Numbers: V11272779 and W01288273 PLATEAU TIBIAL PE IB II-64 12.5, PPB30144, Lot Numbers: V09243783, W01278844, and W09359228 PLATEAU TIBIAL PE IB II-64 17.5, PPB30148, Lot Numbers: W06335185 and W06344258 PLATEAU TIBIAL PE IB II-64 20, PPB30150, Lot Number: V05194572 PLATEAU TIBIAL PE IB II-69 8.5, PPB30160, Lot Numbers: V11272780 and W01278845 PLATEAU TIBIAL PE IB II-69 10, PPB30162, Lot Numbers: V09243785, V09244054, and W01278846 PLATEAU TIBI

    FDA Recall
    Terminated ·Wright Medical Technology Inc·Product code LPH·September 5, 2012

    Villa Sistemi Rotograph EVO 3D X-ray

    FDA Recall
    Terminated ·Villa Radiology Systems LLC·Product code MUH·August 5, 2015

    Torque wrench used on the bolts for the Symbia T2 model 10275008, Symbia Intevo Excel model 10764801, Symbia Intevo 16 model 10764804, Symbia Evo model 10910500, and Symbia Evo Excel model 10910501 devices.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code KPS·September 18, 2017