Events

Recall of Device Recall Aquatec Fixed Backrest

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Invacare Corporation.

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
    68399
  • Event Risk Class
    Class 2
  • Event Number
    Z-2023-2014
  • Event Initiated Date
    2014-06-25
  • Event Date Posted
    2014-07-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-04-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127538
  • 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
    The aquatec¿ fixed backrest withstands a load of only 250 newtons at uneven load. this may result in the fixed backrest becoming detached from the frame.
  • Action
    The recall notification will be sent to the two consignees informing them of the recall and to notify their customers. The letter will include a provider letter, customer letter, provider response card and impacted units listing.

Device

Device Recall Aquatec Fixed Backrest
  • Model / Serial
    Mobile Shower and Toilet commode Aquatec Ocean (Model # 1534327), Ocean VIP (Model # 1470713 and 1470793) and Ocean E-VIP (Model # 1525707).
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed in PA and Canada.
  • Product Description
    Aquatec Fixed Backrest - accessory for Mobile Shower and Toilet commode Aquatec Ocean, Ocean VIP and Ocean E-VIP family.
  • Manufacturer
    Invacare Corporation

Manufacturer

Invacare Corporation
  • Manufacturer Address
    Invacare Corporation, 1200 Taylor St, Elyria OH 44035-6248
  • Manufacturer Parent Company (2017)
    Invacare Corporation
  • Source
    USFDA