Events

Recall of VersaCell X3 Solution and VersaCell X3 Expansion Pack

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

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
    68320
  • Event Risk Class
    Class 3
  • Event Number
    Z-1832-2014
  • Event Initiated Date
    2014-04-25
  • Event Date Posted
    2014-06-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-04-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127332
  • 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
    Equipment, laboratory, general purpose, labeled or promoted for a specific medical use - Product Code LXG
  • Reason
    The keyboard and monitor may not be properly secured to the monitor arm.
  • Action
    Siemen's Healthcare Diagnostics sent an Urgent Medical Device Correction letter dated April 25, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete and return teh Field Correction Effectiveness Check form attached to the letter within 30 days by fax to 302-631-7597. Inspect the monitor, keyboard and bracket assembly. If the screw and washer assembly is secure as shown in Figure 1, the monitor and keyboard assembly is safe to use. After making adjustments or repositioning the monitor, keyboard and bracket assembly, inspect the screw adn washer to ensure it is ssecure as shown in Figure 1. If there is a gap between the underside of the monitor support bracket and cylindrical mounting feature as shown in Figure 2, contact your Siemens technical support representative to schedule a service visit as soon as possible. Front load and manage samples directly on the connected instruments until your Siemens technical support representative addresses the issue. Customers were instructed to retain the letter with their laboratory records, and forward the letter to those who may have received the affected product. Customers with questions were instructed to contact their Siemens Customer Care Center or their local Siemens technical support representative. For questions regarding this recall call 877-229-3711.

Device

VersaCell X3 Solution and VersaCell X3 Expansion Pack
  • Model / Serial
    Siemens Material Numbers: Instrument 10793839, Expansion Pack 10913528
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including Iowa and New York and Internationally to Canada, Chile, France, India, Italy, Malaysia, Peru, Korea, and the United Kingdom.
  • Product Description
    VersaCell X3 Solution and VersaCell X3 Expansion Pack, a robotic laboratory sample-management system. It connects up to 3 instruments and provides a user interface that routes samples, reduces manual tasks and consolidates results.
  • Manufacturer
    Siemens Medical Solutions Diagnostics

Manufacturer

Siemens Medical Solutions Diagnostics
  • Manufacturer Address
    Siemens Medical Solutions Diagnostics, 62 Flanders-Bartley Rd, Flanders NJ 07836-4715
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA