Devices

Device Recall Emax Consoles

  • Model / Serial
    SC2100 System Console Emax 2 Plus; SC2101 System Console, Single Port with irrigation; SC2102 System Console, Single Port, without Irrigation.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    HDE
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA Nationwide including the states of: AZ, CA, FL, KY, ME, MI, MO, OH, PA, TN, TX , VA, and the countries of: Australia, Egypt, Italy, Japan, Switzerland, Taiwan, and Turkey;
  • Product Description
    ***REF SC2100***eMax 2 Plus Console***SN G 10307653002*** || Product Usage: || The RPM of the Motor Handpiece may be less than 80,000 RPM (approximately 72,000 RPM) in the free running state when using the optional Hand Control. The low Motor Handpiece RPM would only be experienced in the Free running state (Hand Control fully depressed and no load on the cutting bur). This condition would not affect the power output of the Handpiece in the loaded working range (typically 50,000 to 70,000 RPM.
  • Manufacturer
    The Anspach Effort, Inc.
  • 1 Event

Manufacturer

The Anspach Effort, Inc.
  • Manufacturer Address
    The Anspach Effort, Inc., 4500 Riverside Drive, Palm Beach Gardens FL 33410-4235
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA

One device with a similar name

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Device Recall Emax Consoles
  • Model / Serial
    SC2100 System Console Emax 2 Plus; SC2101 System Console, Single Port with irrigation; SC2102 System Console, Single Port, without Irrigation;
  • Product Classification
    Cardiovascular Devices
  • Device Class
    HDE
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA Nationwide including the states of: AZ, CA, FL, KY, ME, MI, MO, OH, PA, TN, TX , VA, and the countries of: Australia, Egypt, Italy, Japan, Switzerland, Taiwan, and Turkey;
  • Product Description
    ***REF SC2102***eMax 2 Plus Console, Single Port, no Irrigation***SN G16307882402*** || Product Usage: || The eMax console is intended to operate the eMax system which is used for cutting and shaping bone including spine and cranium. The RPM of the Motor Handpiece may be less than 80,000 RPM (approximately 72,000 RPM) in the free running state when using the optional Hand Control. The low Motor Handpiece RPM would only be experienced in the Free running state (Hand Control fully depressed and no load on the cutting bur). This condition would not affect the power output of the Handpiece in the loaded working range (typically 50,000 to 70,000 RPM).
  • Manufacturer
    The Anspach Effort, Inc.