Events

Rappel de Device Recall ADVIA 120

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.

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
    65852
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2114-2013
  • Date de mise en oeuvre de l'événement
    2013-06-26
  • Date de publication de l'événement
    2013-08-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-02-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120549
  • 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
    Counter, cell, automated (particle counter) - Product Code GKL
  • Cause
    The advia 120 optics cover or hood is located on the very top of the advia 120 analyzer. when the optics cover is raised, it is supported by two gas struts (smn 10309266) attached to the cover on the left and right sides. over time, it is possible that these struts may lose their effectiveness and fail to support the optics cover in the open position. this could cause the cover to fall during maintenance procedures.
  • Action
    Siemens sent an Urgent Device Correction Letter dated June 26, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed of the ADVIA 120 system displays a problem when raising and supporting the optics cover, immediately contact your service provider to arrange to have the cover struts serviced. If the optics cover will not stay in the up position, as required, do not perform maintenance procedures on the optics area until the hood struts have been replaced. Siemens field support will be proactively replacing the optics cover hood struts on a regular preventive maintenance cycle based on the age of the system. Please forward this notification to whomever you may have distributed this product We apologize for the inconvenience that this situation has caused. Thank you for your patience and continued support. This response form is to confirm receipt of the enclosed Siemens Healthcare Diagnostics Urgent Device Correction dated June 2013 regarding Optics Cover Struts (SMN 10309266). Please read each question and indicate the appropriate answer. Fax this completed form to Siemens Healthcare diagnostics at the fax number indicated at the bottom of this page. PLEASE FAX THIS COMPLETED FORM TO THE TECHNICAL SOLUTIONS CENTER AT (302) 631-7597.

Device

Device Recall ADVIA 120
  • Modèle / numéro de série
    All serial numbers
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Austria, Australia, Belgium, Bosnia - Herzegovina, China, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hungary, Iceland, India, Indonesia, Ireland, Iraq, Israel, Italy, Japan, Kenya, Republic of Korea, Kuwait, Lebanon, Lithuania, Luxembourg, Martinique, Malaysia, Netherlands, Norway, New Zealand, Philippines, Poland, Portugal, Romania, Russian Republic, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom and Vietnam.
  • Description du dispositif
    ADVIA 120 Hematology Analyzer, Catalog Numbers SMN 10360958 and 10360959 . || The ADVIA 120 is a hematology system that utilizes the principles of flow cytometry in order to provide complete blood counts.
  • Manufacturer
    Siemens Healthcare Diagnostics

Manufacturer

Siemens Healthcare Diagnostics
  • Adresse du fabricant
    Siemens Healthcare Diagnostics, 511 Benedict Ave, Tarrytown NY 10591-5005
  • Source
    USFDA