BEUDAMED
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    Agfa Computed Radiography Systems with DX-G Digitizer. DX-G Digitizers haved the same intended use as the predicate devices. they are intended to use in providing diagnostic images to aid the physician with diagnosis. DX-G Digitizers provide the ability to use both standand needle phosphor image plates and can be used with either Musica or Musica 2. In the US, Agfa's Computed Radiography Systems with DX-G Digitizers are not intended for use in mammography.

    FDA Recall
    Terminated ·AGFA Corp.·Product code MQB·December 6, 2011

    DX-G Digitizer, manufactured by Agfa-Gevart NV, Mortsel, Belgium.

    FDA Recall
    Terminated ·AGFA Corp.·Product code MQB·October 8, 2010

    Power cord for QVue Continuous Cardiac Output (CCO)/SO2 computer, list #s 52230-04-03, 52230-04-05, 52230-04-07, 52230-04-09, 52230-04-11, 52230-04-13, 52230-04-15, 52230-04-17, 52230-04-25, 52230-04-31, 52230-04-33, AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA.

    FDA Recall
    Terminated ·Hospira Inc·Product code dxg·August 11, 2009

    Power cord for Q2Plus/Continuous Cardiac Output (CCO)/SO2 Computer, list #s 56711-04-01, 56711-04-03, 5671-04-05, 56711-04-51, AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA.

    FDA Recall
    Terminated ·Hospira Inc·Product code dxg·August 11, 2009

    Power cord for Oximetrix 3 SO2/CO Cardiac Output Computer, list # 50130-04-07, AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA.

    FDA Recall
    Terminated ·Hospira Inc·Product code dxg·August 11, 2009

    Power cord for Optional Thermal Printer (For use with Model 3300 COC), Oximetrix 3 SO2/CO Computer, Q-Vue CCO Computer and Q2 CCO/SO2 Computer, List Number 50132-04-05, AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA.

    FDA Recall
    Terminated ·Hospira Inc·Product code dxg·August 11, 2009

    Vigilance II Monitor Model: VIG2/VIG2E Software: versions 00.51, 00.60, 00.61, 00.62, 00.63, 00.64, 00.67, 00.69, 00.71, 00.73. Product Usage: The Vigilance II CCO/SvO2/CEDV Monitor is indicated for use in patients requiring monitoring of hemodynamic parameters, including cardiac output, oximetry and right ventricular, ejection, fraction, and end diastolic volume.

    FDA Recall
    Terminated ·Edwards Lifesciences, Llc·Product code DXG·September 12, 2008

    Edwards Vigilance II Continuous Cardiac Output/Oximetry/Volumetric (CCO/SvO2/CEDV) Monitor Model: VIG2/VIG2E Software Versions: 00.51,00.60, 00.61, 00.62, 00.63, 00.64, 00.67, 00.69, Edwards Lifesciences LLC., Irvine, CA 92614

    FDA Recall
    Terminated ·Edwards Lifesciences, Llc·Product code DXG·May 17, 2007

    HCS3011 AV Loop Kit For use with Transonic CO status System Only, -HCS3021 AV Loop Kit For use with Transonic CO status System Only. Product Usage: is indicated for use in patients greater than or equal to 2 years old with arterial and venous lines in the diagnostic assessment of cardiovascular status including cardiac output and associated hemodynamic parameters.

    FDA Recall
    Terminated ·Transonic Systems Inc 34 Dutch Mill Rd Warren Road Business Park Ithaca NY 14850-9785·Product code DXG·March 28, 2013

    CM 50-001-01 Injectate Kit, accessory device to LiDCOunity v2 Monitor - Product Usage: intended to administer lithium dilution indicator (tube administrative set).

    FDA Recall
    Terminated ·Lidco Ltd 16 Orsman Road London United Kingdom·Product code DXG·November 19, 2020

    PulsioFlex Monitoring System, Part Number: 6882747, Model Number: PC400 3 R0. Usage: The PulsioFlex Monitoring System is indicated in patients where cardiovascular and circulatory volume status monitoring is necessary. If a patient s biometric data are entered, the PulsioFlex Monitor presents the derived parameters indexed. -With the PiCCO Module cardiac output is determined both continuously through pulse contour analysis and intermittently through thermodilution technique. Both are used for the determination of other derived parameters. -With the CeVOX oximetry module connected to a compatible oximetry probe, the PulsioFlex Monitoring System measures continuous venous oxygen saturation to assess oxygen delivery and consumption. The use of the PulsioFlex Monitoring System is indicated in patients where cardiovascular and organ monitoring is useful. This includes patients in surgical, medical, and other hospital units

    FDA Recall
    Terminated ·GETINGE US SALES LLC·Product code DXG·June 5, 2019

    Power cord for Model 3300 Cardiac Output Computer, List # 41245-04-03, AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA.

    FDA Recall
    Terminated ·Hospira Inc·Product code dxg·August 11, 2009

    Power cord for Q2 Continuous Cardiac Output (CCO)/SO2 Computer, list #s 52235-04-01, 52235-04-03, 52236-04-05, 52235-04-07, 52235-04-11, AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA.

    FDA Recall
    Terminated ·Hospira Inc·Product code dxg·August 11, 2009

    Edwards' MHANM8 Pressure Slave Cable, Part Number:693657001 The Edwards Lifesciences Analog Slave Cable is used to transfer monitoring output from patient monitors to the analog input ports of the Vigileo Monitor series or compatible Edwards monitoring systems. This cable has instrument specific connectors.

    FDA Recall
    Terminated ·Edwards Lifesciences, Llc·Product code DXG·June 25, 2010

    The Cogent Hemodynamic Monitoring System. REF58400-000, GTIN 00840619099459; REF 58400-000R, GTIN 0087709094314; REF 58403, GTIN 00840619079505; REF 58401, GTIN 00840619079499 - Product Usage: intended for patients for whom the monitoring of continuous cardiac output and calculated hemodynamic parameters is indicated for diagnostic and prognostic evaluation by a clinician. The target population includes Critical Care Patients, Trauma Patients, and Cardiac Surgery Patients.

    FDA Recall
    Terminated ·ICU Medical, Inc.·Product code DXG·February 14, 2020

    icumedical Cogent" Hemodynamic Monitoring System - Product Usage: intended for patients for whom the monitoring of continuous cardiac output and calculated hemodynamic parameters is indicated for diagnostic and prognostic evaluation by a clinician.

    FDA Recall
    Terminated ·ICU Medical, Inc.·Product code DXG·November 9, 2020

    JAMSHIDI (TJ) NEEDLE BM ASP MAC [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 3.5, d.) 8G x 6, e.) 11G x 6]; STERILE;

    FDA Recall
    Terminated ·Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845·Product code FSH·February 23, 2017

    JAMSHIDI (TJ) NEEDLE BONE MARROW [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 4, d.) 8G x 6, e.) 11G x 6]; STERILE;

    FDA Recall
    Terminated ·Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845·Product code FSH·February 23, 2017

    00720504022 ACETAB.CUPW/SH,0DEG,22MMX40MM 00720504222 ACETAB.CUPW/SH,0DEG,22MMX42MM 00720504622 ACETAB.CUPW/SH,0DEG,22MMX46MM 00720504828 ACETAB.CUPW/SH,0DEG,28MMX48MM 00720505228 ACETAB.CUPW/SH,0DEG,28MMX52MM 00720505628 ACETAB.CUPW/SH,0DEG,28MMX56MM 00720505828 ACETAB.CUPW/SH,0DEG,28MMX58MM 00720506028 ACETAB.CUPW/SH,0DEG,28MMX60MM 00720506228 ACETAB.CUPW/SH,0DEG,28MMX62MM 00720506428 ACETAB.CUPW/SH,0DEG,28MMX64MM 00721004222 ACETAB.CUPW/SH,10DEG,22MMX42MM 00721004422 ACETAB.CUPW/SH,10DEG,22MMX44MM 00721005028 ACETAB.CUPW/SH,10DEG,28MMX50MM 00721005228 ACETAB.CUPW/SH,10DEG,28MMX52MM 00721005628 ACETAB.CUPW/SH,10DEG,28MMX56MM 00721006428 ACETAB.CUPW/SH,10DEG,28MMX64MM 00721006628 ACETAB.CUPW/SH,10DEG,28MMX66MM 00721006828 ACETAB.CUPW/SH,10DEG,28MMX68MM 00721007028 ACETAB.CUPW/SH,10DEG,28MMX70MM 00725504222 ACETAB.CUP, 0 DEG, 22MM X 42MM 00725504622 ACETAB.CUP, 0 DEG, 22MM X 46MM 00725504626 ACETAB.CUP, 0 DEG, 26MM X 46MM 00725504828 ACETAB.CUP, 0 DEG, 28MM X 48MM 00725505232 ACETAB.CUP, 0 DEG, 32MM X 52MM 00725505432 ACET CUP, 0 DEG, 32MM X 54MM 00725505632 ACET CUP, 0 DEG, 32MM X 56MM 00725505828 ACETAB.CUP, 0 DEG, 28MM X 58MM 00725505832 ACET CUP, 0 DEG, 32MM X 58MM 00725506028 ACETAB.CUP, 0 DEG, 28MM X 60MM 00725506032 ACET CUP, 0 DEG, 32MM X 60MM 00725506228 ACETAB.CUP, 0 DEG, 28MM X 62MM 00725506232 ACET CUP, 0 DEG, 32MM X 62MM 00725506428 ACETAB.CUP, 0 DEG, 28MM X 64MM 00725506432 ACET CUP, 0 DEG, 32MM X 64MM 00725506628 ACETAB.CUP, 0 DEG, 28MM X 66MM 00725506632 ACET CUP, 0 DEG, 32MM X 66MM 00725506828 ACETAB.CUP, 0 DEG, 28MM X 68MM 00725506832 ACET CUP, 0 DEG, 32MM X 68MM 00725507028 ACETAB.CUP, 0 DEG, 28MM X 70MM 00725507032 ACET CUP, 0 DEG, 32MM X 70MM 00726004222 ACETAB.CUP,10 DEG, 22MM X 42MM 00726004828 ACETAB.CUP,10 DEG, 28MM X 48MM 00726005028 ACETAB.CUP,10 DEG, 28MM X 50MM 00726005228 ACETAB.CUP,10 DEG, 28MM X 52MM 00726005232 ACETAB.CUP,10 DEG, 32MM X 52MM 00726005432 ACET CUP, 10 DEG, 32MM X 54MM 00726005632 ACET CUP, 10 DEG, 32MM X 56MM 00726005832 ACET CUP, 10 DEG, 32MM X 58MM 00726006032 ACET CUP, 10 DEG, 32MM X 60MM 00726006428 ACETAB.CUP,10 DEG, 28MM X 64MM 00726006432 ACET CUP, 10 DEG, 32MM X 64MM 00726006628 ACETAB.CUP,10 DEG, 28MM X 66MM 00726006632 ACET CUP, 10 DEG, 32MM X 66MM 00726006828 ACETAB.CUP,10 DEG, 28MM X 68MM 00726006832 ACET CUP, 10 DEG, 32MM X 68MM 00726007028 ACETAB.CUP,10 DEG, 28MM X 70MM 00726007032 ACET CUP, 10 DEG, 32MM X 70MM

    FDA Enforcement
    Class II ·Terminated·Zimmer Trabecular Metal Technology, Inc.·June 22, 2016

    Solitaire-35 Peek Solitaire Anterior Spinal System. The Solitaire-35 is an intervertebral body fusion device.

    FDA Enforcement
    Class II ·Terminated·Ebi, Llc·October 9, 2013