Events

Recall of Pressure IQ Evolve Mattress

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Arjo Hospital Equipment 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
    68235
  • Event Risk Class
    Class 2
  • Event Number
    Z-1247-2015
  • Event Initiated Date
    2014-09-01
  • Event Date Posted
    2015-03-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-01-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127196
  • 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
    Mattress, flotation therapy, non-powered - Product Code IKY
  • Reason
    The firm received complaints regarding multiple mattresses were showing failures resulting in pressure ulcers.
  • Action
    On 9/1/14 the recalling firm sent out a letter to their customers notifying them of an updated IFU for the recalled device. The letter also requested the customers to verify the quantity of the product they currently have on hand.

Device

Pressure IQ Evolve Mattress
  • Model / Serial
    All Pressure IQ Evolve mattresses equipped with the 60g pods, manufactured January 2012-December 2013.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    Pressure IQ Evolve Mattress; Non-powered mattress replacement system. || Intended for patients with medium to high risk for developing pressure ulcers while on a mattress.
  • Manufacturer
    Arjo Hospital Equipment AB

Manufacturer

Arjo Hospital Equipment AB
  • Manufacturer Address
    Arjo Hospital Equipment AB, HANS MICHELSENSGATAN 10, Malm¿ Sweden
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    USFDA