Events

Recall of Dimension(R) Vista(R) VLYTE(R)

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
    60644
  • Event Risk Class
    Class 2
  • Event Number
    Z-0646-2012
  • Event Initiated Date
    2011-10-31
  • Event Date Posted
    2012-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-12-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106124
  • 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
    Firm has confirmed that specific lots of v-lyte(r) fluids may contribute to reduced v-lyte(r) integrated multisensor on-board use life as demonstrated by increases in: urine sodium qc results within 48 hours after installation of a new imt sensor. the results can be elevated approximately 10-20% which may cause qc recovery being out of acceptable ranges. patient urine sodium results may also b.
  • Action
    Siemens sent an Urgent Field Safety Notice letter dated October, 2011 to all consignees. The letter identified the product, description of problem, and actions to be taken. Consignees were instructed to replace the affected lots of V-LYTE(R) Fluids with alternate lots if available and recalibrate. If no alternate lots were available they were recommended to replace the V-LYTE(R) Integrated Multisensor every 24 hours or when indicated by QC until the impacted lots were no longer in use. For replacement product consignees were instructed to contact the Siemens Customer Service at 888-588-3916 or your local Siemens Service Center. Consignees were advised to complete and return the enclosed Customer Response Sheet via fax to the Technical Solutions Center at 302-631-8467. For questions or concerns contact Siemens Technical Solutions Center at 800-441-9250 for further assistance.

Device

Dimension(R) Vista(R) VLYTE(R)
  • Model / Serial
    Lot number KE1H01, KE1J01, and KE1K01
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) iin the states of : AL, AZ, AR, CA, CO, CT, DE, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MS, MO, MT, NE, NH, NV, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, VT, UT, VA, WA, WV, WI, WY including Puerto Rico and Washington, DC and the countries of: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Italy, Netherlands, Norway, Portugal, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Switzerland, Canada, Australia, Japan, New Zealand, Malaysia, and South Korea.
  • Product Description
    Dimension(R) Vista(R) V-LYTE(R) Diluent (K835) || Product Usage: V-LYTE(R) Diluent is for the automatic dilution of samples processed in the V-LYTE(R) Integrated Multisensor on the Dimension Vista(R) system
  • 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