Events

Rappel de Device Recall EasyLink(TM) Informatics System included with the Dimension Vista System

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Siemens Healthcare Diagnostics, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    62460
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2242-2012
  • Date de mise en oeuvre de l'événement
    2012-05-29
  • Date de publication de l'événement
    2012-08-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-04-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110905
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Calculator/data processing module, for clinical use - Product Code JQP
  • Cause
    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
  • Modèle / numéro de série
    Part Number: 1000034805, Version 5.0 and Version 5.0 Service Pack 1 through 4
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    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.
  • Description du dispositif
    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.
  • Adresse du fabricant
    Siemens Healthcare Diagnostics, Inc., 500 GBC Drive, Mailstop 514, PO BOX 6101, Newark DE 19714-6101
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    USFDA