Events

Rappel de Device Recall Ultraview Universal Clinical Workstation (UCW) Model 90385

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 Spacelabs Medical Incorporated.

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
    30797
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0422-05
  • Date de mise en oeuvre de l'événement
    2005-01-07
  • Date de publication de l'événement
    2005-01-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-01-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36615
  • 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
    Display, Cathode-Ray Tube, Medical - Product Code DXJ
  • Cause
    Weakness of the swivel base for the universal clinical workstation may result in the unit falling from its mounted position endangering users and patients.
  • Action
    All US customers were sent a Medical Device Recall letter on 1/7/2005 describing how to examine monitors for the defect and to discontinue use of any suspect unit s until examintaion by a Field Service Engineer . International customers will be notified via email or letter on 1/14/2005. Follow up contact by Customer Support and Global Support is planned for any customer not responding with a FAX-back form.

Device

Device Recall Ultraview Universal Clinical Workstation (UCW) Model 90385
  • Modèle / numéro de série
    Universal Ultraview Clinical Workstation Model 90385 base versions with Revision M or earlier. This recall involves certain units within the serial number range SN: 385-000337 to SN: 385-111440. The firm indicated that not all serial numbers within this range are affected by this recall, but only those units with the specified Revision M or earlier base which have not already been updated.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    The firm completed a survey of their customer records and determined a total of 12,306 units were installed from January of 1994 through December of 1997. 7,601 units were originally sold to 767 US accounts and 4,705 units were sold to 102 international accounts. The firm estimates approximately 3000 units worldwide are still in operation with the Revision M or earlier base.
  • Description du dispositif
    Ultraview Universal Clinical Workstation System Model 90385.
  • Manufacturer
    Spacelabs Medical Incorporated

Manufacturer

Spacelabs Medical Incorporated
  • Adresse du fabricant
    Spacelabs Medical Incorporated, 5150 220th Ave Se, Issaquah WA 98029-6834
  • Source
    USFDA