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Vista de la lista Vista de las tarjetas
  • Dispositivo 136
  • Fabricante 19
  • Evento 124969
  • Implante 0
eye station
  • Modelo / Serial
  • Descripción del producto
    md
  • Manufacturer
    MERGE HEALTHCARE
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de eye station
cadstream merge
  • Modelo / Serial
  • Descripción del producto
    md
  • Manufacturer
    MERGE HEALTHCARE
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de cadstream merge
cadstream filter pure gecadstream
  • Modelo / Serial
  • Descripción del producto
    md
  • Manufacturer
    MERGE HEALTHCARE
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de cadstream filter pure gecadstream
merge eye station and eye care pacs
  • Modelo / Serial
  • Descripción del producto
    md
  • Manufacturer
    EMERGO
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de merge eye station and eye care pacs
merge eye station
  • Modelo / Serial
  • Descripción del producto
    md
  • Manufacturer
    MERGE HEALTHCAREORPORATED
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de merge eye station
efilm workstation / efilm lite
  • Modelo / Serial
  • Descripción del producto
    md
  • Manufacturer
    MERGE HEALTHCAREORPORATED
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de efilm workstation / efilm lite
Device Recall Merge Eye Station
  • Modelo / Serial
    136 T1700 Capture Stations 46 T5810 Capture Stations
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) including the states of : CA, CO, CT, FL, HI, IL, IN, LA, MD, MA,M I, MN, MS. MK. NY, NC,ND, OH, OK, OR, PA, RI, TN, VA, WA and WV., and the countries of Canada and United Kingdom.
  • Descripción del producto
    Merge Eye Station. || f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Imaging Systems (OIS). || Model number 136 T1700 Capture Stations & 46 T5810 Capture Stations.
  • Manufacturer
    Merge Healthcare, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Merge Eye Station
Device Recall Merge Cardio
  • Modelo / Serial
    Version 10.1
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    Merge Cardio software. || Product Usage: || Merge Cardio is an integrated cardiovascular information system classified as a picture archiving and communications system.
  • Manufacturer
    Merge Healthcare, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Merge Cardio
Device Recall Merge Cardio software
  • Modelo / Serial
    Versions 10.1 and 10.1.1
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Image processing system.
  • Manufacturer
    Merge Healthcare, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Merge Cardio software
Device Recall iConnect Merge Enterprise Archive system
  • Modelo / Serial
    Version: 8.80, 8.80.0.1, 8.80.0.2, 8.80.1.1, 8.80.2, and 8.80.2.1
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Distribution to: CO and OK.
  • Descripción del producto
    iConnect Enterprise Archive. The firm name on the label is Merge Healthcare, Hartland, WI. || iConnect Enterprise Archive is intended for use as a vendor neutral archive for storage and communications of medical images and data.
  • Manufacturer
    Merge Healthcare, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall iConnect Merge Enterprise Archive system
Device Recall RadSuite
  • Modelo / Serial
    Versions V8.30.6, 8.30.6.1, 8.30.6.2, and 8.30.6.3
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution to: CO and OK.
  • Descripción del producto
    RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. || RadSuite provides a means to distribute, display, and store diagnostic-quality medical images in electronic format.
  • Manufacturer
    Merge Healthcare, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall RadSuite
Device Recall RadSuite
  • Modelo / Serial
    Versions: 5.30.7, 5.30.7 HF0429E, 5.30.7 HF0441E, 5.30.7 HF0446E, 5.30.7 HF0470E, 5.30.7 HF0473E, 5.30.8, 5.30.8 HF0477E, 5.30.8 HF0490E, 5.30.8 HF0495 SB0508E, 5.30.8 HF0495E, 5.30.8 HF0495E, SB504E, 5.30.8 HF0550, 5.30.8 SB0485E, 5.30.8 SB0486E, 5.30.X SB0381E, 5.35.1, 5.35.1 HF0487E, 5.35.1 HF0489E, 5.35.2, 5.35.3, 5.35.4, and 5.35.4 HF0513
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distribution was made to AL, AZ, CA, IL, MD, MA, MI, MO, NV, NJ, NC, OH, PA, TN, and VA. Government distribution was made to OK. There was no foreign/military distribution.
  • Descripción del producto
    RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
  • Manufacturer
    Merge Healthcare, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall RadSuite
Device Recall RadSuite software
  • Modelo / Serial
    This potential patient safety issue is only present in the following versions when a reverse workflow is used: 2004-R6.x, 5.10.x, 5.20, 5.25, 5.30.1, 5.30.2, 5.30.2 SB0344, 5.30.3, 5.30.4, 5.30.4 HF0418E, 5.30.5, 5.30.5 HF0404E, 5.30.5 HF0413E, 5.30.5 HF390E, 5.30.5 SB0368, 5.30.6, 5.30.6 HF0405E, 5.30.6 HF0406E, 5.30.7, 5.30.7 HF0429E, 5.30.7 HF0441E, 5.30.7 HF0446E, 5.30.7 HF0470E, 5.30.7 HF0473E, 5.30.8, 5.30.8 HF0477E, 5.30.8 HF0490E, 5.30.8 HF0495 SB0508E, 5.30.8 HF0495E, 5.30.8 HF0495E SB504E, 5.30.8 HF0550, 5.30.8 SB0485E, 5.30.8 SB0486E, 5.30.X SB0381E, 5.35.1, 5.35.1 HF0487E, 5.35.1 HF0489E, 5.35.2, 5.35.3, 5.35.4, 5.35.4 HF0513, 5.35.4 HF0518, 5.35.4 HF0528, 5.35.4 HF0531, 5.35.4 HF0535, 5.35.4 HF0546, 8.30.0.  NOTE: The standard workflow is not impacted.  .
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distribution was nationwide to medical facilities. Government distribution was made to LA and OK.
  • Descripción del producto
    RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
  • Manufacturer
    Merge Healthcare, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall RadSuite software
Device Recall Merge Unity Z3D software
  • Modelo / Serial
    Version 11.0
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution to states of: CA, PA, TX, and MT.
  • Descripción del producto
    Merge Unity Z3D software. || Merge Unity PACS (formerly DR Systems PACS) is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems.
  • Manufacturer
    Merge Healthcare, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Merge Unity Z3D software
Device Recall Merge PACS
  • Modelo / Serial
    Software versions 6.0.2.0 MR2, 6.0.3.0 MR3, 6.0.3.1 MR3 CU1
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA and Australia.
  • Descripción del producto
    Merge PACS software. The firm name on the label is Merge Healthcare, Inc., Hartland, WI. || Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.
  • Manufacturer
    Merge Healthcare, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Merge PACS
Device Recall Merge PACS Software V6.0.2.0 MR2
  • Modelo / Serial
    Versions: V6.0.2.0 MR2 and earlier
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    The software was distributed to medical facilities nationwide. Government distribution was made to MN. Foreign distribution was made to Australia and to the United Kingdom. There was no military distribution.
  • Descripción del producto
    Merge PACS software. Product was distributed under the AMICAS label, Brighton, MA, but labeling was later changed to Merge Healthcare, Hartland, WI.
  • Manufacturer
    Merge Healthcare, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Merge PACS Software V6.0.2.0 MR2
Device Recall iConnect Access used with Ortho PACS software
  • Modelo / Serial
    iConnect Access V4.0 or earlier with any version of Ortho PACS and iConnect Access V4.1 with Ortho PACS V5.1.2 and earlier.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distribution was made to medical facilities nationwide and to one foreign medical facility in New Zealand. There was no military or government distribution.
  • Descripción del producto
    iConnect Access used with Ortho PACS software provides medical specialists with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP (e.g., internet) networks.
  • Manufacturer
    Merge Healthcare, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall iConnect Access used with Ortho PACS software
Device Recall iConnect Access
  • Modelo / Serial
    iConnect Access V4.0 or earlier with any version of Merge PACS and iConnect Access V4.1 with Merge PACS V6.5.4 or earlier
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distribution was made to medical facilities nationwide and to one foreign medical facility in New Zealand. There was no military or government distribution.
  • Descripción del producto
    iConnect Access used with Merge PACS software provides medical specialists with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP (e.g., internet) networks.
  • Manufacturer
    Merge Healthcare, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall iConnect Access
Device Recall Merge PACS
  • Modelo / Serial
    Versions: V6.5.5, 6.5.6, 6.5.7, 6.5.8, 6.5.9, 6.6.0, 6.6.1, 6.6.1.1, 6.6.2
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: US (Nationwide) and countries of: Australia, Belgium, Canada, Jordan, New Zealand, and the United Kingdom.
  • Descripción del producto
    Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, Wisconsin. || Merge PACS 6.0 is software intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.
  • Manufacturer
    Merge Healthcare, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Merge PACS
Device Recall Merge PACS
  • Modelo / Serial
    Versions: V6.0 MR4 CU 1-11, 6.1.0, 6.1.1, 6.1.1.1, 6.1.2, 6.1.3, 6.1.3.1, 6.2.0, 6.2.1, 6.2.2, 6.2.2.1, and 6.2.3.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA, New Zealand, and United Kingdom.
  • Descripción del producto
    Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. || Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.
  • Manufacturer
    Merge Healthcare, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Merge PACS
Device Recall Merge HEMO software
  • Modelo / Serial
    Software versions 8.10, 9.10, 9.20.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    The medical facilities who currently have the affected versions are located nationwide. There was government distribution but no military or foreign distribution.
  • Descripción del producto
    Merge HEMO software.
  • Manufacturer
    Merge Healthcare, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Merge HEMO software
Device Recall Merge OfficePACS
  • Modelo / Serial
    Software versions: 4.0, 4.1, 4.1.1, 4.1.2, and 4.2
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    The software was distributed nationwide to medical facilities. There was no government/military/foreign distribution.
  • Descripción del producto
    Merge OfficePACS software. The firm name on the label is Merge Healthcare, Hartland, WI. || OfficePACS is intended for the manipulation and displaying of medical images by a suitable licensed and qualified healthcare professional. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards. OrthoPACS also uses such images, in conjunction with templates for prosthetic devices, for the purposes of choosing the nature and characteristics of the prosthetic device to be used when planning a potential surgical procedure.
  • Manufacturer
    Merge Healthcare, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Merge OfficePACS
Device Recall Merge OfficePACS3.xDat
  • Modelo / Serial
    Version 3.4
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distribution was made to medical facilities located in AL, AZ, CA, CO, CT, FL GA, ID, IL, KY, MA, MO, NE, NH, NJ, NY, NC, OK, PA, SC, TN, VA, and WA. There was no government/military/foreign distribution.
  • Descripción del producto
    Merge OfficePACS software. The firm name on the label is Merge Healthcare, Heartland, WI.
  • Manufacturer
    Merge Healthcare, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Merge OfficePACS3.xDat
Device Recall RadSuite, a picture archive and communications system.
  • Modelo / Serial
    Versions 5.30.0, 5.30.1, 5.30.2, 5.30.2 SB0344, 5.30.3, 5.30.4, 5.30.4 HF0418E, 5.30.5, 5.30.5 HF0404E, 5.30.5 HF0413E, 5.30.5 HF390E, 5.30.5 SB0368, 5.30.6, 5.30.6 HF0405E, 5.30.6 HF0406E, 5.30.7, 5.30.7 HF0429E, 5.30.7 HF0441E, 5.30.7 HF0446E, 5.30.7 HF0470E, 5.30.7 HF0473E, 5.30.8, 5.30.8 HF0477E, 5.30.8 HF0490E, 5.30.8 HF0495 SB0508E, 5.30.8 HF0495E, 5.30.8 HF0495E SB504E, 5.30.8 HF0550, 5.30.8 SB0485E, 5.30.8 SB0486E, 5.30.X SB0381E, 5.35.1, 5.35.1 HF0487E,  5.35.1 HF0489E, 5.35.2, 5.35.3, 5.35.4, 5.35.4 HF0513, 5.35.4 HF0518, 5.35.4 HF0528, 5.35.4 HF0531, 5.35.4 HF0535, 5.35.4 HF0546, 5.35.4 HF0555, 5.35.4 HF0555.1, 5.35.4 HF0555.2, 5.35.4 HF0555.3, 5.35.4 HF0560,  5.35.4 Powerscribe Validation, 5.35.5, 5.35.5 From CCS, 5.35.5.1, 8.30.0, 8.30.1, 8.30.3, 8.30.3.1, 8.30.4, 8.30.5, 8.30.6, 8.30.6.1, 8.30.6.2, 8.30.6.3, 8.30.7, 8.30.7.1, 8.30.7.2, 8.30.7.3, 8.30.7.3-Hopkins, 8.30.7.4, 8.30.7.5, 8.30.7.5.b, 8.30.7.6, 8.30.7.7, 8.30.7.8.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution to the states of : MN, WI, IL, PA, AL, MO, MT, AZ, CA, OH, FL, SC, MI, TN, CO, NV, IN, NY, MD, AR, KS, NY, IN, IA, TX, OK, NC, WA and DC.
  • Descripción del producto
    RadSuite, a picture archive and communications system. Model Numbers Versions 5.30.0, 5.30.1, 5.30.2, 5.30.2 SB0344, 5.30.3, 5.30.4, 5.30.4 HF0418E, 5.30.5, 5.30.5 HF0404E, 5.30.5 HF0413E, 5.30.5 HF390E, 5.30.5 SB0368, 5.30.6, 5.30.6 HF0405E, 5.30.6 HF0406E, 5.30.7, 5.30.7 HF0429E, 5.30.7 HF0441E, 5.30.7 HF0446E, 5.30.7 HF0470E, 5.30.7 HF0473E, 5.30.8, 5.30.8 HF0477E, 5.30.8 HF0490E, 5.30.8 HF0495 SB0508E, 5.30.8 HF0495E, 5.30.8 HF0495E SB504E, 5.30.8 HF0550, 5.30.8 SB0485E, 5.30.8 SB0486E, 5.30.X SB0381E, 5.35.1, 5.35.1 HF0487E, || 5.35.1 HF0489E, 5.35.2, 5.35.3, 5.35.4, 5.35.4 HF0513, 5.35.4 HF0518, 5.35.4 HF0528, 5.35.4 HF0531, 5.35.4 HF0535, 5.35.4 HF0546, 5.35.4 HF0555, 5.35.4 HF0555.1, 5.35.4 HF0555.2, 5.35.4 HF0555.3, 5.35.4 HF0560, || 5.35.4 Powerscribe Validation, 5.35.5, 5.35.5 From CCS, 5.35.5.1, 8.30.0, 8.30.1, 8.30.3, 8.30.3.1, 8.30.4, 8.30.5, 8.30.6, 8.30.6.1, 8.30.6.2, 8.30.6.3, 8.30.7, 8.30.7.1, 8.30.7.2, 8.30.7.3, 8.30.7.3-Hopkins, 8.30.7.4, 8.30.7.5, 8.30.7.5.b, 8.30.7.6, 8.30.7.7, 8.30.7.8.
  • Manufacturer
    Merge Healthcare, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall RadSuite, a picture archive and communications system.
Device Recall Merge Hemo
  • Modelo / Serial
    Merge Hemo with software versions 9.10, 9.20.0, 9.20.1, 9.20.2, 9.30, 9.40.0, 9.40.1, 9.40.2 are affected only if used with any Masimo PHASEIN EtCO2 module
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including IL, SC, WI, AL, CT, CA, LA, NM, TX, OK, GA, IA, OH, FL, CO, TN, NY, NC, MA, AR, MO, HI, ND, AK, UT, WV, WA, AZ, MI, PA, ME.
  • Descripción del producto
    Merge Hemo, 9.10, 9.20.0, 9.20.1,9.20.2, 9.30, 9.40.0, 9.40.1, 9.40.2 with Massimo PHASEIN End Tidal CO2 (EtCO2) module. Merge Hemo (formerly named HeartSuite Hemodynamics) monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure.
  • Manufacturer
    Merge Healthcare, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Merge Hemo
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