Events

Recall of Device Recall Dimension Vista(R) Intelligent Lab Systems, Dimension Vista(R) 500 and Dimension Vista(R) 1500 Rel

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
    65408
  • Event Risk Class
    Class 2
  • Event Number
    Z-0430-2014
  • Event Initiated Date
    2013-05-20
  • Event Date Posted
    2013-12-02
  • 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=118790
  • 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
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Reason
    There is the potential for the vial volume of "in use" vista calibrators, controls, or sample diluent to incorrectly revert to full volume when removed and reloaded. dimension vista(r) 500 and dimension vista(r) 1500 - reloaded vista vials - limited to systems using software versions 3.4 and 3.5.1.
  • Action
    A notification letter was sent to consignees in May 2013.

Device

Device Recall Dimension Vista(R) Intelligent Lab Systems, Dimension Vista(R) 500 and Dimension V...
  • Model / Serial
    Dimension Vista(R) 500 - Siemens Material Number 10284473 and Dimension Vista(R) 1500 - Siemens Material Number 10444801
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: USA (nationwide) and iinternationally to Canada.
  • Product Description
    Dimension Vista(R) 500 and Dimension Vista(R) 1500 - Reloaded Vista Vials - limited to systems using software versions 3.4 and 3.5.1. || Diagnostic device intended to determine a variety of analytes in human body fluids.
  • 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