Events

Recall of Device Recall Dimension Vista Intelligent Lab 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
    71315
  • Event Risk Class
    Class 2
  • Event Number
    Z-2054-2015
  • Event Initiated Date
    2015-05-21
  • Event Date Posted
    2015-07-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137300
  • 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
    Two software issues may occur in vista software version 3.6.1. issue #1: samples may stop processing without notification. issue #2: timing issue in vista 1500 may cause wrong reagent or no reagent delivery. this may lead to unflagged, unexpected low results and results flagged with assay errors.
  • Action
    Siemens sent an Urgent Medical Device Correction letter dated May 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: For the corresponding issues listed above, please perform the following: Issue 1: If you experience this situation, sample processing can be resumed using the step(s) below: Step 1: From the Operation Icon select PAUSE, then immediately return to the Operation Icon and select Cancel PAUSE. Sample aliquotting should immediately resume. Step 2: If sample processing does not resume after Step 1, wait until the instrument displays System Ready, then restart the system software per the Vista Operator Guide, Section 2, Controlled Shutdown-Restart procedure. Issue 2: To prevent the Reagent Servers from temporarily losing synchronization, Siemens recommends setting the Auto Dispose option to No for methods assigned to Reagent Server 2 (see instructions below). These empty or expired reagent cartridges will now remain on the instrument and require the operator to unload them. Please consult your Vista Operators Guide or method Instructions for Use when results with flags and/or errors occur. We apologize for the inconvenience this situation may cause. 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

Device Recall Dimension Vista Intelligent Lab System
  • Model / Serial
    Siemens Material Number (SMN): 10284473, 10488224, 10444801, 10444802
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - Nationwide Distribution including Puerto Rico., and the countries of : Austria, Australia, Belgium, Canada, Denmark, France, Finland, Germany, Japan, Italy, New Zealand, Netherlands, Czech Republic, Portugal, Republic Korea, Norway, Spain, Switzerland, Slovakia, Saudi Arabia, Slovenia, and United Kingdom,
  • Product Description
    Siemens Healthcare Diagnostics Dimension Vista Systems, used with the Dimension Vista Intelligent Lab System software version 3.6.1. In vitro diagnostic analyzer.
  • 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