Events

Recall of Device Recall Molift Smart 150

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

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
    64512
  • Event Risk Class
    Class 2
  • Event Number
    Z-1343-2013
  • Event Initiated Date
    2013-02-15
  • Event Date Posted
    2013-05-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-07-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116530
  • 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
    Lift, patient, non-ac-powered - Product Code FSA
  • Reason
    The leg spreading mechanism will fail to hoist and collapse if assemble incorrectly by the user.
  • Action
    Molift Group AS issued a Field Safety Notice letter to all affected customers. The letter identified the affected products, problem and actions to be taken to the Smart hoists that are already in use. Customers were instructed to make sure that all affected customers receive this information and encorage to increase attention until the affected product has been upgraded. For questions contact your local Molift representative or Customer Service at: groupsales@molift.com.

Device

Device Recall Molift Smart 150
  • Model / Serial
    Art #: 0920008; Serial Number range 20941 to 27299.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution: CA, FL, GA, ID, IL, KY, MA, ME, MI, MN, NC, NH, NJ, NM, NV, NY, OH, OK, PA, TN, TX, VT, WA and Hawaii. Foreign Distribution:: Australia, Austria; Belgium, Denmark, Finland, France, Germany, Iceland, Israel, Italy, Japan, Netherlands, New Zealand, Norway, Spain, Sverige, Switzerland, United Kingdom.
  • Product Description
    Molift Smart 150
  • Manufacturer
    Moller Vital

Manufacturer

Moller Vital
  • Manufacturer Address
    Moller Vital, Hadelandsvegan 2,, P.o. Box 408, Gjovik Norway
  • Source
    USFDA