Devices

Device Recall Merge Hemo

  • Model / 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
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    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

Manufacturer

Merge Healthcare, Inc.

2 devices with a similar name

Learn more about the data here

Device Recall Merge HEMO software
  • Model / Serial
    Software versions 8.10, 9.10, 9.20.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The medical facilities who currently have the affected versions are located nationwide. There was government distribution but no military or foreign distribution.
  • Product Description
    Merge HEMO software.
  • Manufacturer
    Merge Healthcare, Inc.
Device Recall Merge Hemo software
  • Model / Serial
    Versions 6.10, 6.10.1, 6.10.2, 6.10.3, 7.10, 7.20, 7.20.1, 8.10.0, 8.20, 9.10.0, 9.20, 9.20.2, 9.20.3, 9.30, 9.40, 9.40.1, 9.40.2, and 9.40.3
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure
  • Manufacturer
    Merge Healthcare, Inc.