Events

Rappel de Device Recall Rotating IV Pole

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 Ohmeda Medical.

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
    79452
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1181-2018
  • Date de mise en oeuvre de l'événement
    2017-12-01
  • 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=162347
  • 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
    Stand, infusion - Product Code FOX
  • Cause
    There is the potential for the rotating iv pole to fall. a fall could result in an injury to a bystander holding the patient or to the operator.
  • Action
    On December 1, 2017 an URGENT MEDICAL DEVICE CORRECTION letter was issued to customers notifying of the recall. The letter requested customers to discontinue use of the affected Rotating IV poles and remove from Service. Place affected Rotating IV poles in a quarantine marked area. A GE Service Representative will contact you to arrange for the removal & replacement of a new IV pole. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative. For further questions, please call (410) 888-5376.

Device

Device Recall Rotating IV Pole
  • Modèle / numéro de série
    Model Number(s): 6600-0851-800 Affected lot codes are within LAU13921134 - LAU14720444
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    USA (nationwide)
  • Description du dispositif
    Rotating IV Pole || Rotating IV Pole falls under the category classified as capital equipment, an optional accessory that may be purchased to facilitate attachment and consolidation of patient equipment to one central patient care area. Devices commonly attached to IV poles include IV pumps, feeding pumps, and infusion fluid bags. Products used on: Giraffe OmniBed, Giraffe Warmers, Panda Warmers and Giraffe Incubators and Giraffe Shuttle. The IV pole also can be mounted to the Care Plus Incubator and Panda IWS.
  • Manufacturer
    Ohmeda Medical

Manufacturer

Ohmeda Medical
  • Adresse du fabricant
    Ohmeda Medical, 8880 Gorman Rd, Laurel MD 20723-5800
  • Société-mère du fabricant (2017)
    General Electric Company
  • Source
    USFDA