Events

Recall of Siemens User Defined Method Flex Assignment/Dimension Vista 500 Dimension Vista 1500 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
    66585
  • Event Risk Class
    Class 2
  • Event Number
    Z-0851-2014
  • Event Initiated Date
    2013-10-07
  • Event Date Posted
    2014-01-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-08-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122654
  • 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
    When utilizing the routine inventory screen to enter a user defined method (empty) flex the system may assign the user defined method flex to a different flex that is currently in inventory on the system, and then use the incorrect flex cartridge to process the user defined method.
  • Action
    Siemens sent a Urgent Medical Device Correction letter dated October 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please use the following actions if using Vista SW Versions 3.5.1 and below to prevent the issue from occurring: 1. When assigning a User Defined (EMPTY) Flex, use the Advanced Inventory Screen per the Operators Guide. 2. Verify that EMPTY Flex is no longer listed in the inventory before proceeding with any testing. 3. If the EMPTY Flex is still listed in the inventory, contact your Siemens Customer Care Center - Technical Solutions for assistance. Please retain this letter with your laboratory records and forward this letter to those who may have received this product. Discuss the content of this letter with your Medical Director. We apologize for the inconvenience this situation has caused. If you have any questions, please contact your Siemens Customer Care Center - Technical Solutions at (800-441-9250) or your local Siemens technical support representative.

Device

Siemens User Defined Method Flex Assignment/Dimension Vista 500 Dimension Vista 1500 System
  • Model / Serial
    Material numbers 10284473, 10488224, 10444801, and 10444802.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    USA (nationwide) Distribution including Puerto Rico.
  • Product Description
    User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500 System with software version 3.5.1 or lower || User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500 System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities 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