Device Recall Decomat

  • Model / Serial
    Serial numbers 81972 through 82063; and SEV0141098 through SEV0304112.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide. Medical facilities in AL, CA, CO, LA, MA, MI, MN, MO, NC, NH, NM, OK, PA, TX, WA, and WI.
  • Product Description
    Model 8666 Washer/Disinfector with holding tank heater option. Firm on label is Getinge Disinfection AB, Vaxjo, Sweden.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Getinge/Castle, Inc., 1777 E Henrietta Road, Rochester NY 14623
  • Source
    USFDA