Events

Recall of Device Recall Siemens Luminos dRF, Ysio or Uroskop Omnia systems

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
    68785
  • Event Risk Class
    Class 2
  • Event Number
    Z-2292-2014
  • Event Initiated Date
    2014-07-07
  • Event Date Posted
    2014-09-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-02-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128661
  • 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
    System, x-ray, fluoroscopic, image-intensified - Product Code JAA
  • Reason
    It was discovered that during a rad examination using siemens luminos drf, ysio or uroskop omnia systems with software version vb10c to vb10f and automatic exposure control, a highly unlikely malfunction can result in longer radiation exposure than required. this may also result in an overexposed image that is not of diagnostic quality. as a result the taken examination needs to be repeated. thi.
  • Action
    Siemens had informed all affected customers about this issue via Customer Safety Advisory Notice XP023/13/S (dated June 3, 2013) reported under C&R; # 2240869-05/16/13-0013-C. A corresponding software update to fix the issue was originally planned to be rolled out by May 2014. The originally scheduled roll out date could not be met and to ensure that this new software version works accurately Siemens incorporated a comprehensive monitoring phase. Siemens has now scheduled the roll out for the software version VB10J to be completed by end of October 2014. A letter, dated July 7, 2014, with important safety information was sent to end users to notify them that the new software version VB10J will be introduced to solve the potential malfunction of the generator.

Device

Device Recall Siemens Luminos dRF, Ysio or Uroskop Omnia systems
  • Model / Serial
    model numbers 10094200, 10281163, 10281013, 10094910 with multiple serial numbers
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    Siemens Luminos dRF, Ysio or Uroskop Omnia systems. || The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies.
  • 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