Events

Rappel de Device Recall Maquet Medical 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 Maquet Medical Systems USA.

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
    69560
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0993-2015
  • Date de mise en oeuvre de l'événement
    2014-08-21
  • Date de publication de l'événement
    2015-01-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-11-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130952
  • 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
    Medical device data system - Product Code OUG
  • Cause
    The wrong movement results on the magnus or table. the button commands on the tegris touchscreen for lower leg up and upper leg down are switched in the software for the integration with the magnus operating table system.
  • Action
    Maquet sent an Urgent Medical Device Field Correction Letter dated August 21, 2014, to all affected customers via Federal Express. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to take the following measures until the issue is corrected: The TEGRIS equipped with a software module version up to 2.1.X.X should not be used in conjunction wiht a MAGNUS operating table system. All other MAQUET operating tables are not affected. A MAQUET service representative would contact them and arrange to have their TEGRIS software module updated. Customers with questions were instructed to contact MAQUET Technical Support at 1-888-627-8383 (press option 3, followed by option 1, then option 1 again. For questions regarding this recall call 973-709-7000.

Device

Device Recall Maquet Medical Systems
  • Modèle / numéro de série
    part number: 1703.35AO, with software version up to 2.1.x.x.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution including NE, NY and PA.
  • Description du dispositif
    TEGRIS System manufactured by MAQUET GMBH in Germany || The Maquet Tegris OR Integration System is designed to be used as the central operating unit in an operating room. The integration system has two main functions: Recording and distribution of images and videos and interaction with medical and non-medical devices.
  • Manufacturer
    Maquet Medical Systems USA

Manufacturer

Maquet Medical Systems USA
  • Adresse du fabricant
    Maquet Medical Systems USA, 45 Barbour Pond Dr, Wayne NJ 07470-2094
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    USFDA