Device Recall ICON

  • Model / Serial
    All lots
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide
  • Product Description
    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

Manufacturer

  • Manufacturer Address
    Blackstone Medical, Inc., 1211 Hamburg Tpke, Suite 300, Wayne NJ 07470
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

7 devices with a similar name

Learn more about the data here

  • Model / 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
  • Product Classification
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    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
  • Model / 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.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    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
  • Model / Serial
    Version: 8.80, 8.80.0.1, 8.80.0.2, 8.80.1.1, 8.80.2, and 8.80.2.1
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution to: CO and OK.
  • Product Description
    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
  • Model / Serial
    Versions 3.0.1, 3.1, and 3.2
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distribution was made to medical facilities nationwide. Foreign distribution was also made.
  • Product Description
    iConnect Access software. The firm name on the label is Merge Healthcare, Hartland, WI.
  • Manufacturer
  • Model / Serial
    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.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    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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