Events

Recall of Siemens Uroskop Access

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
    62988
  • Event Risk Class
    Class 2
  • Event Number
    Z-2341-2012
  • Event Initiated Date
    2012-04-30
  • Event Date Posted
    2012-09-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112203
  • 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
    Siemens has discovered a possible hazard to patients or hospital personnel when tilting the uroskop access system starting with serial number 6076. when tilting the table on the uroskop access table, the motor may become disconnected and the entire table assembly may fall on the floor.
  • Action
    Siemens sent a Update instructions letter dated April 2012, to all affected customers. The safety instruction letter identified the product the problem and the action needed to be taken by the customer. The update has been completed successfully. The customer has been informed of the benefits of improvements resulting from this update. Further questions please call (610) 219-4834.

Device

Siemens Uroskop Access
  • Model / Serial
    Model number 5756130 -- serial numbers 6076, 6078, 6080, 6081, and 6082.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: USA including states of: IN, MI, MS, TN and TX.
  • Product Description
    Siemens Uroskop Access. || Fluoroscopic, image intensified 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