Events

Rappel de Device Recall ADVIA Centaur XPT 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
    76485
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1537-2017
  • Date de mise en oeuvre de l'événement
    2017-02-02
  • Date de publication de l'événement
    2017-02-23
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-06-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153342
  • 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
    Multiple software issues, which may affect the operation and workflow of the system. potential for an apparent delay to testing when these issues occur. the software issues affecting the analyzer may impact all analytes available on the advia centaur xpt system test menu.
  • Action
    Siemens sent an Urgent Medical Device Correction letter ( UMDC) dated February 2, 2017. An Urgent Field Safety Notice letter ( UFSN) dated February 2017, was also sent to foreign customers. Customers must follow instructions in the UMDC and UFSN letters. For questions, please contact your Siemens Customer Care Center or your local Siemens Technical Support Representative. For further questions, please call (312) 275-7795.

Device

Device Recall ADVIA Centaur XPT System
  • Modèle / numéro de série
    All Serial Numbers; Software versions V1.0.1 (Bundle 1.0.912 SMN 10819704), V1.0.2 (Bundle 1.0.1086 SMN 11219806), V1.0.3 (Bundle 1.0.1108 SMN 11220781, 11219656), V1.1 (Bundle 1.1.243 SMN 11221979, 11222064) and V1.2 (Bundle: 1.2.223.0 SMN: 11222258, 11223813).
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution - US Distribution to the states of : NH, MD, MS, MN, IL, TX, CA and WA, and to the countries of : Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Greece, Guadeloupe, Hungary, India, Indonesia, Iran, Ireland, Italy, Japan, Jordan, Latvia, Malaysia, Myanmar, Netherlands, New Zealand, Norway, P.R. China, Peru, Philippines, Poland, Portugal, Qatar, Republic of Korea, Saudi Arabia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, U.A.E., United Kingdom, Uruguay, Vatican City, and Vietnam.
  • Description du dispositif
    ADVIA Centaur XPT System Software Versions V1.0.1, V1.0.2, V1.0.3, V1.1 and V1.2. The ADVIA Centaur XPT System is a stand-alone, continuous operation, immunochemistry analyzer that performs the following functions: aspirates and dispenses samples; Performs dilutions; Adds reagents; Incubates reaction vessels; Separates solid and liquid wastes; Measures photon emissions; Performs data reduction; Collects and maintains patient demographics and results.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • Adresse du fabricant
    Siemens Healthcare Diagnostics, Inc., 511 Benedict Ave, Tarrytown NY 10591-5005
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    USFDA