Events

Rappel de Device Recall Neptune 2 Rover Ultra

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 Instruments Div. 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
    63634
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0455-2013
  • Date de mise en oeuvre de l'événement
    2011-05-24
  • Date de publication de l'événement
    2012-12-03
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-05-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114396
  • 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
    Apparatus, suction, ward use, portable, ac-powered - Product Code JCX
  • Cause
    Beginning may 24, 2011 stryker neptune 2 (n2) waste management systems castors were replaced with a new castor design because investigation found the old design had the potential for the casters to bind compromising the rover's ability to roll. this can result in additional strain on the operator, due to multiple exposures resulting in back pain.
  • Action
    Stryker Instruments sent a "STRYKER NEPTUNE 2 ULTRA 120V & 230V WASTE MANAGEMENT SYSTEM" letter dated June 22, 2011 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers were asked to complete and return a Reply Form via fax to Stryker at 269-906-9121 or email to sales.service@stryker.com. Technical questions should be addressed to Neptune Field Service at 800-800-4236 ext. 5052.

Device

Device Recall Neptune 2 Rover Ultra
  • Modèle / numéro de série
    Part 0702-002-000 (230v)   Lot 0733700353 through 1036100423
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and Pacific countries, and the countries of EEMEA, Canada, Latin America, and Japan.
  • Description du dispositif
    Neptune¿ 2 Rover - ULTRA ~230V ~ 50 Hz 12A || REF 0702-002-000, Rx Caution, consult accompanying documents || Consult instructions for use, Max Vacuum; 21.0 in-Hg, 530 mm-Hg, || The Neptune Waste Management System consists of a mobile rover unit || used to suction and collect fluid waste, small debris and electrocautery || smoke from a surgical site. Mobility allows the rover unit to be || relocated to a waste disposal area where the rovers collection canisters || can be emptied, via the docking station. || Intended to be used in the Operating Room, Surgical Centers and Doctors Offices to collect and dispose of surgical fluid waste as well as collect smoke from electrocautery or laser devices.
  • Manufacturer
    Stryker Instruments Div. of Stryker Corporation

Manufacturer

Stryker Instruments Div. of Stryker Corporation
  • Adresse du fabricant
    Stryker Instruments Div. of Stryker Corporation, 4100 E Milham Ave, Portage MI 49002-9704
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA