Events

Rappel de Device Recall Maquet

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 Cardiovascular Us Sales, Llc.

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
    66051
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2275-2013
  • Date de mise en oeuvre de l'événement
    2013-08-19
  • Date de publication de l'événement
    2013-09-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-04-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121376
  • 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
    Maquet has identified a potential issue that might occur because of the lack of an emergency stop button on a secondary touch screen display on the tegris system.
  • Action
    Maquet sent an Urgent Medical Device Recall Letters/Field Action Response Forms dated August 19, 2013, via Federal Express to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were informed that a MAQUET authorized service technician would contact them to arrange an appointment to equip their system with a second emergency stop button that would be located in close proximity to the secondary touch screen. Customers were instructed to complete and return the enclosed Field Action Response Form acknowledging their receipt and understanding of the communiction by emailing a scanned copy to FieldActions@maquet.com or via fax at 973-807-1658. Customers with questions were asked to contact their MAQUET representative or MAQUET Technical Support at 888-627-8383, option 3. For questions regarding this recall call 973-709-7361.

Device

Device Recall Maquet
  • Modèle / numéro de série
    Class 1 exempt Device Listing #D122038  Tegris Base System 1703.01X0 OR TAblet Module 1703.71A0  Secondary 19" touchscreen - part number 1707.05A0  The above product is affected only when used in combination with   Tegris base system 1703.01X0 OR Table Control 1703.71A0
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including NY and PA and internationally to Australia, Brazil, Canada, Germany, Hong Kong, Japan, Sweden.
  • Description du dispositif
    TEGRIS system || Four labels of the Tegris System include: || Emergency button (1703.72) || MAQUET GmbH & Co. KG || Kehler-Strabe 31 || Baden-Wuerttemberg || 76437 Rastatt, Germany || Touch screen (elo) || Elo TouchSystems 301 Constitution Drive || Menlo Park, CA 94025 || www.elotouch.com || Manufacturer: Tyco Electronics || Brand Name: Elo Touch Systems || Made in China || Tegris system (1703.01) || MAQUET GmbH & Co. KG || Kehler Strabe 31 || 76437 Rastatt, Germany || OR Table Module (1703.71) || MAQUET GmbH & Co. KG || Kehler Strabe 31 || Baden-Wuerttemberg || 76437 Rastatt, Germany || Designed to be used as the central operating system in an operating room. The integration system has two main functions. -recording and distribution of images and videos -interaction with medical and non-medical devices. The system has a modular design and comprises the basic units as well as s various optional modules,which may be used or integrated in conjunction with the basic unit. TEGRIS is operated using a touchscreen. Medical devices that can be operated by TEGRIS include OR tables an OR lights. In the case of OR tables and OR lights, the main functions of these devices may be separated, e.g. adjustment of OR tables or switching the OR lights on.off. TEGRIS has no effected on the primary operating functions of the original control device. TEGRIS does not provide any other functions in addition to these primary operating functions. The purpose of TEGRIS namely the central operation of these various devices, is dependant on the individual devices. Please refer to the operating instructions of the individual devices for instructions. The integrated surgical safety checklist is a raft and must be modified to meet local requirements and approved by the User. TEGRIS is intended for short-term use pursuant to Appendix IX of the Directive 93/42/EEC of medical products in medical rooms in accordance with Group 1 and 2 VDR 0100-710, providing, among other things, protection against electric shock and connections for potential equalization lines. Intended for the following users: medical experts
  • Manufacturer
    Maquet Cardiovascular Us Sales, Llc

Manufacturer

Maquet Cardiovascular Us Sales, Llc
  • Adresse du fabricant
    Maquet Cardiovascular Us Sales, Llc, 45 Barbour Pond Drive, Wayne NJ 07470
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    USFDA