Events

Recall of Device Recall Swift Mobil Shower Chair

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
    65401
  • Event Risk Class
    Class 2
  • Event Number
    Z-1807-2013
  • Event Initiated Date
    2013-05-23
  • Event Date Posted
    2013-07-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-10-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118779
  • 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
    Chair, adjustable, mechanical - Product Code INN
  • Reason
    Etac is voluntarily conducting a field correction of the etac swift mobil shower chair. if the swift mobil shower chair loses a caster and thus becomes instantly unstable, there is potiential risk for harm or injury.
  • Action
    Etac sent an "URGENT FIELD CORRECTION" letter dated May 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers.

Device

Device Recall Swift Mobil Shower Chair
  • Model / Serial
    Affected Serial numbers: 3829 to 11028 (same series for all Swift Mobil products)
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    International distribution: Austria, Australia, Belgium, Brazil, Canada, Czech Republic, Denmark, Esonia, Finland, France, Great Britain, Germany, Greece, Hong Kong, Ireland, Isreal, Iceland, Italy, Kingdom of Bahrain, Kuwait, Lithuania, Netherlands, Norge, New Zealand, Spain, Switzerland, Sweden, and United Arab Emirates.
  • Product Description
    Swift Mobil shower chair, Swift Mobil 160 shower chair, and Swift Mobil Tilt shower chair. || Height adjustable four wheeled shower chairs for persons of various weights.
  • 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