Events

Recall of Device Recall CentraLink" Data Management System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Healthcare Diagnostics, 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
    71362
  • Event Risk Class
    Class 2
  • Event Number
    Z-1957-2015
  • Event Initiated Date
    2015-05-19
  • Event Date Posted
    2015-07-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-04-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137451
  • 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
    Calculator/data processing module, for clinical use - Product Code JQP
  • Reason
    Siemens healthcare diagnostics has determined that the sample query function that includes instrument or instrument group as search criteria may not return all samples from the dimension vista systems if onboard aliquot support rules are configured in the centralink system.
  • Action
    Siemens sent an Urgent Medical Device Correction letter dated May 19, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions to be Taken by the Customer When using any of the CentraLink sample queries, do not select Instrument or Instrument Group criteria for Dimension Vista 500 or Dimension Vista 1500. This would also include any preconfigured queries, commands or tool bar buttons that may use these criteria. Your local Siemens service provider will be contacting you to verify and/or update the configuration of your CentraLink system. Please retain this letter with your laboratory records, and forward this letter to those who may have received this product. We apologize for the inconvenience this situation may cause. If you have any questions, please contact your Siemens Customer Care Center or your local Siemens technical support representative. For further questions please call (800) 441-9250.

Device

Device Recall CentraLink" Data Management System
  • Model / Serial
    Product: Siemens CentraLink Data Management System, v14.0.5 Material Number (SMN)10811741, 10811742, 10811743, 10814298, 10814877, 10814880,10814881,   Product: CentraLink Data Management System, v14.0.8 Material Number (SMN)10815474, 10816519, 10816520, 10816521, 10816522, 10816523, 10816524, 10817180, 10817181
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - Nationwide Distribution and to the countries of : Belgium, Canada, Czech Republic, Denmark, France, Germany, Italy, Netherlands, Saudi Arabia, Spain, Switzerland and United Kingdom.
  • Product Description
    CentraLink" Data Management System; software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The CentraLink software consolidates data || from all connected instruments so that an operator can review and edit patient and quality control results from a single location.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • Manufacturer Address
    Siemens Healthcare Diagnostics, Inc., 500 Gbc Dr Ms 514, PO BOX 6101, Newark DE 19702-2466
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA