Events

Rappel de Device Recall PowerLOAD Cot Fastening 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 Stryker Medical Division of Stryker Corporation.

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
    79630
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1389-2018
  • Date de mise en oeuvre de l'événement
    2018-03-12
  • Date de publication de l'événement
    2018-05-01
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162855
  • 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
    The power load floor plates which hold the ambulance cot anchors in place during patient transport, may be broken.
  • Action
    On February 27, 2018, affected customers received an Urgent Medical Device Correction Notification via FedEx notifying them of the issue and potential hazard. For distributed units, the four Floor Plate Attachment Brackets that hold the anchor in place will be replaced in the field by Strykers field service personnel. Customers will be asked to return a business reply form to acknowledge that they have received and understand the notification. For further questions, please call (269) 389-8306.

Device

Device Recall PowerLOAD Cot Fastening System
  • Modèle / numéro de série
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and to the countries of : Australia, Canada, France, Germany, Hong Kong, Italy, India, Netherlands, Portugal, Saint Martin, Switzerland, United Kingdom
  • Description du dispositif
    Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000, UDI: 07613327261523 || Power-LOAD is intended to assist with loading and unloading of a compatible wheeled stretcher (ambulance cot) to and from a transport vehicle and to secure the ambulance cot during transport. The device has a maximum safe working load of 870 lb (395 kg), which includes the weight of the ambulance cot, patient, and equipment attached to the cot (such as oxygen bottles, monitors, and pumps). The intended users of the device are trained professionals, including emergency medical service and medical care center personnel, as well as medical first responders, service technicians and installers.
  • Manufacturer
    Stryker Medical Division of Stryker Corporation

Manufacturer

Stryker Medical Division of Stryker Corporation
  • Adresse du fabricant
    Stryker Medical Division of Stryker Corporation, 3800 E Centre Ave, Portage MI 49002-5826
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA