Events

Recall of Device Recall ROTH MOBELI

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

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
    77424
  • Event Risk Class
    Class 2
  • Event Number
    Z-2626-2017
  • Event Initiated Date
    2017-05-30
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=156038
  • 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
    Aid, transfer - Product Code IKX
  • Reason
    Roth mobeli grab handles could detach and patient could fall if the eos system operator does not follow instructions. before each use, the operator must examine the vacuum safety indicator to check the vacuum is monitored and sufficient and the grab handle correctly attached. do not use grab handles to help patient up. the handles are only for stabilizing the patients hand or arm in the eos cabin.
  • Action
    EOS Imaging sent Field Safety Notice letter and Removal Instructions May 30, 2017. Customers are to immediately discontinue use of the grab handles and remove them from all affected units from inventory and return to a EOS Imaging. For further questions please call (678) 564-5400.

Device

Device Recall ROTH MOBELI
  • Model / Serial
    ROTH Catalogue Numbers 14002 96 S and 14002 25 S only.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of : Pennsylvania, Massachusetts, Minnesota, Alabama, Michigan, Texas and Washington.
  • Product Description
    ROTH MOBELI Grab Handles used with EOS System: MOBELI Stabi Vario Grab Handle, ROTH Catalogue Number 14002 96 S, EOS Imaging Catalogue Number 9000111773; and MOBELI Dual Grip Grab Handle, ROTH Catalogue Number 14002 25 S, EOS Imaging Catalogue Number 9000111774.
  • Manufacturer
    EOS Imaging

Manufacturer

EOS Imaging
  • Manufacturer Address
    EOS Imaging, 4 Ieme Etage, 10 rue Mercoeur, Paris France
  • Manufacturer Parent Company (2017)
    EOS Imaging SA
  • Source
    USFDA