Device Recall EncompassTSS

  • Model / Serial
    Serial No: 6101, 6170 and 6267-6613
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: CA, TX, IN, OR, and MO.
  • Product Description
    AccuMax Quantum Complete (Model CU3/CU4), an alternating pressure with turn assist & on demand low air loss system; Encompass Therapuetic Support Systems, Glendale, CA. || The device is intended to treat or prevent decubitus ulcers, extensive burns, urinary tract blockage and to aid circulation.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Encompass Therapeutic Support Systems dba BG North America, 500 N Central Ave Ste 900, Glendale CA 91203-3346
  • Source
    USFDA