Events

Recall of Device Recall Siemens Luminos dRF

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Medical Solutions USA, Inc.

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
    65491
  • Event Risk Class
    Class 2
  • Event Number
    Z-1848-2013
  • Event Initiated Date
    2013-05-07
  • Event Date Posted
    2013-08-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-12-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119218
  • 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
    Interventional fluoroscopic x-ray system - Product Code OWB
  • Reason
    Siemens became aware of an unintended behavior when using the luminos drf with software version vd10a. the possibility exists that a software error may occur causing the table to tilt into an upright position and may collide with the floor. four consignees were notified of this recall by update instruction xp067/12/s -- all four units have been corrected.
  • Action
    Siemens initiated their correction of this product in May, 2013 by sending an Safety Update Instruction XP067/12S to resolve the software error to all affected customers. All units have been corrected. Further questions please call (610)-219-6300.

Device

Device Recall Siemens Luminos dRF
  • Model / Serial
    Model number 10094200, serial numbers 4024, 4077, 4043 and 4051
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution including the states of CA, IN, NJ and OK.
  • Product Description
    Siemens Luminos dRF Fluoroscopic X-Ray system || Fluoroscopic X-Ray system
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc, 51 Valley Stream Pkwy, Malvern PA 19355
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA