Events

Rappel de Device Recall Dimension Vista Intelligent Lab Systems

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
    69687
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0838-2015
  • Date de mise en oeuvre de l'événement
    2014-11-05
  • Date de publication de l'événement
    2014-12-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-10-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131351
  • 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
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Cause
    Customer complaints of discrepant flagged and/or un-flagged patient and qc results. reagent probe performance may decline more quickly than anticipated and have an effect on assays with similar formulations when processed sequentially on the same reagent server.
  • Action
    An Urgent Medical Device Correction, dated November 2014, was issued on November 4th, 2014 to inform customers that Siemens Healthcare Diagnostics has confirmed that reagent probe performance on Dimension Vista systems may decline more quickly than anticipated and have an effect on assays with similar formulations when processed sequentially on the same reagent server. Instructions for replacing an associated reagent probe were provided to resolve the issue. Customers are to retain the letter for their laboratory records and forward it to anyone who has received the affected product. Customers are also to complete and return the Field Correction Effectiveness Check Form. Customer should direct their questions to their Siemens Customer Care Center - Technical Solutions at 1-800-441-9250 or their local Siemens technical support representative.

Device

Device Recall Dimension Vista Intelligent Lab Systems
  • Modèle / numéro de série
    Material Nos.: 10284473, 10488224,  10444801, and 10444802
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- Austria, Australia, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Italy, Japan, Malaysia, Netherlands, New Zealand, Norway, Portugal, Republic Korea, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Switzerland, United Kingdom, and United States.
  • Description du dispositif
    Dimension Vista 500 Intelligent Lab System or Dimension Vista 1500 Intelligent Lab System: || 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.
  • Adresse du fabricant
    Siemens Healthcare Diagnostics, Inc., 500 Gbc Dr Ms 514, PO BOX 6101, Newark DE 19702-2466
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    USFDA