Events

Rappel de Skytron EZ Slide Operating Table

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 Skytron, Div. The KMW Group, 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
    74128
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1844-2016
  • Date de mise en oeuvre de l'événement
    2016-04-06
  • Date de publication de l'événement
    2016-05-31
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-07-20
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146394
  • 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
    Table, operating-room, electrical - Product Code GDC
  • Cause
    The potential exists within the identified tables that incorrectly manufactured parts have been used in assembly. if a table is found to have these incorrectly manufactured parts, it is possible for the tables elevation column slide cap to become detached from the elevation column and could result in the loss of control of the table top and injury to the patient or staff.
  • Action
    Skytron sent an Urgent Medical Device Recall letter dated A,pril 4, 2016, to all affected customers. On April 6, 2016, URGENT: Medical Device Recall notifications were sent to the affected hospitals and distributors via certified mail. The notification instructed the hospital to identify and remove the affected product from use. The notification instructs the distributor to contact the hospital to schedule replacement. The recall notification included a description of the reason for the recall, affected product, and consignee responsibilities. The notification did not include instructions for responding to the formal recall notification, however the company did request acknowledgement via follow-up email. Please call Technical Services, at 616-656-1187 or 616-656-6403 with any questions. For after-hours support, please call 1-800-SKYTRON.

Device

Skytron EZ Slide Operating Table
  • Modèle / numéro de série
    Model number 3502. All units. Units entered commercial distribution between April 30, 2014 and July 24, 2014
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution to AL, AZ, CO, IA, WI, PA, TN, MA, TX, MI, FL, MS, LA, and CA.
  • Description du dispositif
    EZ Slide Battery/line powered hydraulic table with removable leg section and 21 top slide || General Purpose Surgical Table || Skytron EZ Slide Operating Table || General Purpose Surgical Table
  • Manufacturer
    Skytron, Div. The KMW Group, Inc

Manufacturer

Skytron, Div. The KMW Group, Inc
  • Adresse du fabricant
    Skytron, Div. The KMW Group, Inc, 5085 Corporate Exchange Blvd SE, Grand Rapids MI 49512-5515
  • Société-mère du fabricant (2017)
    The Kmw Group Inc
  • Source
    USFDA