Events

Recall of Device Recall EasyLink(TM) Informatics System included with the Dimension Vista 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
    62460
  • Event Risk Class
    Class 2
  • Event Number
    Z-2242-2012
  • Event Initiated Date
    2012-05-29
  • Event Date Posted
    2012-08-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-04-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110905
  • 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
    When using the easylink quality control package the system may not perform as intended for multi-rule qc violations [e.G., 2(2s), 4(1s) and 10x], unless configured using the instructions send with the urgent field safety notice. when this situation occurs, qc status may not be flagged appropriately. if auto-verification rules are defined to hold patient results when qc status is out, the patient.
  • Action
    Siemens sent an "URGENT FIELD SAFETY NOTICE" dated May 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Field Correction Effectiveness Check Form was attached for customers to complete and return via fax to 302-631-8467. Contact Siemens Technical Solutions Center at 800-441-9250 for questions regarding this notice.

Device

Device Recall EasyLink(TM) Informatics System included with the Dimension Vista System
  • Model / Serial
    Part Number: 1000034805, Version 5.0 and Version 5.0 Service Pack 1 through 4
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Canada, France, Germany, Spain, Portugal, Italy, Japan, Norway, Australia, Austria, New Zealand, Belgium, Switzerland, Netherlands, Malaysia, Slovenia, South Korea, Denmark, Saudi Arabia, Slovakia, Taiwan, Philippines, Czech Republic, and Singapore.
  • Product Description
    EasyLink Informatic System is included with the Dimension Vista System. The Dimension Vista Integrated System is an in vitro diagnostic device intended tot duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. || The EasyLink Informatics System is classified as a data calculator and processing module for use with in vitro diagnostic devices. The EasyLink is included with the Dimension Vista System and may be used with other Siemens analyzers as a communications and connectivity workstation for integration with laboratory information system (LIS) networks.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • Manufacturer Address
    Siemens Healthcare Diagnostics, Inc., 500 GBC Drive, Mailstop 514, PO BOX 6101, Newark DE 19714-6101
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA