Manufacturers

Custom Ultrasonics, Inc.

4 devices in the database

Device Recall System 83 Plus WasherDisinfector
  • Model / Serial
    All Serial Numbers
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide; USA medical facilities and physicians and Canada
  • Product Description
    System 83 Plus Washer-Disinfector, Endoscope use, DOS based system, Custom Ultrasonics Inc., Buckingham, PA
Device Recall 83 Miniflex with accesory crate
  • Model / Serial
    Serial numbers: 051305-J, 061705-E, 061605-F, and 061705-G.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide-The device was shipped to medical facilities in CA, GA, VA. and the UK.
  • Product Description
    83 plus Mini-flex with accessory crate, Custom Ultrasonics, Inc.
Device Recall Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector
  • Model / Serial
    Multiple serial numbers
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: USA (nationwide) and Internationally to: Canada, Slovakia Republic, Sydney and Peru.
  • Product Description
    Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector.
Device Recall System 83 Plus 2 Endoscope/Washer/Disinfector
  • Model / Serial
    All serial numbers
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution to IN, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD., ME, MI, MN, MO,MS, MT, NC, NE, NH, NJ, NM, NV, NY OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT,WA, WI, WV, and WY.
  • Product Description
    The System 83 Plus, Endoscope Washer/Disinfector || Designed for the simultaneous reprocessing of up to two flexible submersible endoscopes that are used in the gastrointestinal and/or pulmonary tracts.