Events

Rappel de iNX Wheeled Stretcher

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 Ferno-Washington 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
    71983
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2826-2015
  • Date de mise en oeuvre de l'événement
    2015-08-03
  • Date de publication de l'événement
    2015-10-01
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-01-20
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139518
  • 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
    Stretcher, wheeled - Product Code FPO
  • Cause
    Hole elongation in the telescoping load frame channel. a hole elongation could affect the ability of the retention pin to stay seated which is necessary to preclude movement of the telescoping load frame.
  • Action
    Ferno began calling their customers on 8/3/2015. The firm informed their customers of the following: To provide optimal Customer Experience and minimal disruption to your service, the iNX field action involves the following steps: " Exchange of your current iNX with a new iNX; " Participation in a brief training session; and " Inspection of your Ferno Model 175 antler and rail fastening system as requested by the Dept. of Transportation. As you await delivery of your new iNX, it is important you ensure proper function of the fastening system and iNX telescoping load frame.

Device

iNX Wheeled Stretcher
  • Modèle / numéro de série
    Serial #s: 15F001703, 15F001704, 15F001706, 15F001707, 15F001708, 15F001709, 15F001710, 15F001711, 15F001712, 15F001713, 15F001715, 15F001717, 15F001719, 15F001721, 15F001722, 15F001723, 15F001724, 15F001725, 15F001726, 15F001727, 15F001728, 15F001729, 15F001730, 15F001731, 15F001732, 15F001733, 15F001734, 15F001735, 15F001736, 15F001737, 15F001738, 15F001739, 15F001740, 15F001741, 15F001742, 15F001744, 15F001745, 15F001746, 15F001747, 15F001748, 15F001749, 15F001750, 15F001751, 15F001752, 15F001753, 15F001754, 15F001755, 15F001756, 15F001757, 15F001758, 15F001759, 15F001760, 15F001761, 15F001762, 15F001763, 15F001764, 15F001765, 15F001766, 15F001767, 15F001768, 15F001769 5F001770, 15F001771, 15F001772, 15F001773, 15F001774, 15F001775, 15F001776, 15F001777, 15F001778, 15F001779, 15F001780, 15F001781, 15F001782, 15F001783, 15F001784, 15F001785, 15F001786, 15F001787, 15F001788, 15F001789, 15F001790, 15F001791, 15F001793, 15F001794, 15F001795, 15F001796, 15F001797, 15F001798, 15F001804, 15F001805, 15F001806, 15F001807, 15F001808, 15F001809, 15F001810, 15F001811, 15F001812, 15F001813, 15F001814, 15F001815, 15F001816 & 15F001850.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the states of: CO, IA, IL, IN, KY, MD, MN, MO, NC, NJ, NY, OH, OK, OR, TX, VA, WA & WY and the countries of CANADA, AUSTRALIA, UNITED KINGDOM & NEW ZEALAND.
  • Description du dispositif
    Ferno iNX Wheeled Stretcher, Integrated Patient Transport & Loading System || Product Usage: || Stretcher for pre-hospital patient transport.
  • Manufacturer
    Ferno-Washington Inc

Manufacturer

Ferno-Washington Inc
  • Adresse du fabricant
    Ferno-Washington Inc, 70 Weil Way, Wilmington OH 45177-9371
  • Société-mère du fabricant (2017)
    Ferno-Washington Inc.
  • Source
    USFDA