Device Recall ICON

  • Modèle / numéro de série
    All lots
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide
  • Description du dispositif
    Blackstone Medical: || ICON Modular Pedicle Screw System; || P/N's 54-9011 (implant set), 54-9020 (instrument case# I), 54-9030 (instrument case #2), spinal implants.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Blackstone Medical, Inc., 1211 Hamburg Tpke, Suite 300, Wayne NJ 07470
  • Société-mère du fabricant (2017)
  • Source
    USFDA

7 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    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
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distribution was made to medical facilities nationwide and to one foreign medical facility in New Zealand. There was no military or government distribution.
  • Description du dispositif
    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
  • Modèle / numéro de série
    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.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distribution was made to medical facilities nationwide and to one foreign medical facility in New Zealand. There was no military or government distribution.
  • Description du dispositif
    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
  • Modèle / numéro de série
    Version: 8.80, 8.80.0.1, 8.80.0.2, 8.80.1.1, 8.80.2, and 8.80.2.1
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution to: CO and OK.
  • Description du dispositif
    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
  • Modèle / numéro de série
    Versions 3.0.1, 3.1, and 3.2
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distribution was made to medical facilities nationwide. Foreign distribution was also made.
  • Description du dispositif
    iConnect Access software. The firm name on the label is Merge Healthcare, Hartland, WI.
  • Manufacturer
  • Modèle / numéro de série
    All Diacam, Multispect 2, Multispect 3 and e.cam camera systems with ICON workstations with ICON software version 9.5 and the optional Whole Body SPECT software.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide, United Arab Emirates, Argentina, Austria, Australia, Barbados, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Equador, Egypt, France, Germany, Great Britain, Georgia, Greece, Hong Kong, Israel, India, Italy, Jordan, Japan, Korea, Latvia, Mexico, Niger, Norway, New Zealand, Philippines, Pakistan, Poland, Russia, Saudi Arabia, SIngapore, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine and the Netherlands.
  • Description du dispositif
    ICON 9.5 Software used on the ICON workstations designed for use with the E.CAM Emission Imaging Computed Tomography Systems; Siemens Medical Systems, Inc., Nuclear Medicine Group, Hoffman Estates, IL 60195-5203
  • Manufacturer
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