Device Recall System 83 Plus 2 Endoscope/Washer/Disinfector

  • Model / Serial
    All serial numbers
  • Product Classification
  • 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.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Custom Ultrasonics, Inc., 144 Railroad Dr, Ivyland PA 18974-1449
  • Manufacturer Parent Company (2017)
  • Source
    USFDA