Events

Recall of Device Recall Etac Relax

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Etac Supply Center Ab.

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
    71707
  • Event Risk Class
    Class 2
  • Event Number
    Z-2381-2015
  • Event Initiated Date
    2015-07-12
  • Event Date Posted
    2015-08-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-02-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138795
  • 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
    Adaptor, hygiene - Product Code ILS
  • Reason
    The recalling firm has received reports of a malfunction of the relax wall mounted shower seat where the wall bracket has cracked or broken.
  • Action
    Etac sent an Urgent Field Safety Notice dated July 2015 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed that there was no reason for an immediate stop of using Relax, however, as an intermediate precautionary action awaiting replacement, consumers were requested to be observant and inspect the Relax to see if there are visible signs of a crack. Customers with questions were advised to contact their Etac distributor or the Etac coordinator at 1-800-336-7684 or fax 1-704-882-0751.

Device

Device Recall Etac Relax
  • Model / Serial
    The affected products are individually identified within the serial number range: 1-425 regarding Art No. 81703030, 1-205 regarding Art No. 81703050, All distributed regarding Art No. 81703080
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including FL, AZ, and CA.
  • Product Description
    Etac Relax wall mounted shower seat || The Etac Relax is a wall mounted shower seat designed as a seating and standing support for personal hygiene purposes for people with reduced mobility. The Etac Relax shower seat is used for sitting where space is restricted, and can be folded up when not in use. Etac Relax is intended for home use.
  • Manufacturer
    Etac Supply Center Ab

Manufacturer

Etac Supply Center Ab
  • Manufacturer Address
    Etac Supply Center Ab, Langgatan 12, Anderstorp Sweden
  • Manufacturer Parent Company (2017)
    Nordstjernan Ab
  • Source
    USFDA