Events

Recall of Device Recall EncompassTSS

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Encompass Therapeutic Support Systems dba BG North America.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    55074
  • Event Risk Class
    Class 2
  • Event Number
    Z-1216-2010
  • Event Initiated Date
    2010-03-05
  • Event Date Posted
    2010-03-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89827
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    AccuMax Quantum Pressure relief systems - Product Code FNM
  • Reason
    Potential out gasing of the battery and short term ignition of the gas within the control unit enclosure. this failure mode includes a risk for fire.
  • Action
    An "URGENT RECALL NOTIFICATION" letter dated March 5, 2010, was sent to the customers. The letter describes the product, problem and action to be taken by the customers. The customers should immediately discontinue use of the control unit, turn off the unit and disconnect from the wall socket and quarantine the unit away from any patient's room. The customers should immediately examine your inventory and quarantine the products listed; identify and notify any facility where they may have further distributed or transferred the listed products; and complete and return the REPLY/FAX-BACK FORM as soon as possible to Fax: (626) 796-7856 or mail to EncompassTSS, 100 E. Corson Street, Ste 310, Pasadena, CA 91103. Please contact EncompassTSS Customer Service at 800-822-8288 if you have any questions regarding this recall notice.

Device

Device Recall EncompassTSS
  • Model / Serial
    Serial No: 6101, 6170 and 6267-6613
  • Product Classification
    General Hospital and Personal Use Devices
  • 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
    Encompass Therapeutic Support Systems dba BG North America

Manufacturer

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