Events

Rappel de Stryker Medical StairPRO Stair Chair

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 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
    53251
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0149-2010
  • Date de mise en oeuvre de l'événement
    2009-09-02
  • Date de publication de l'événement
    2009-11-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-02-16
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85067
  • 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, Hand-Carried - Product Code FPP
  • Cause
    The front of the handle may become detached from the chair, which could result in a patient fall or an operator injury.
  • Action
    Consignees were sent a letter titled URGENT MEDICAL DEVICE CORRECTION dated 9/9/09, advising them of the problem and to remove the devices from service until they have been repaired. U.S. customers were notified that Stryker will complete the correction while international customers were sent a kit with instructions for completion of the correction. International consignees were told that Stryker will complete the correction if the consignee does not feel comfortable in doing so. Questions or comments regarding this issue should be addressed to Sarah Marie Puterbaugh of Stryker Medical at (800) 869-0770 ext. 6902.

Device

Stryker Medical StairPRO Stair Chair
  • Modèle / numéro de série
    Serial numbers 080340370, 080340371, 080340372, 080340373, 080340374, 080340375, 080340376, 080340377, 080340378, 080340379, 080340380, 080340381, 080340382, 080340383, 080340384, 080340385, 080340386, 080340387, 080340388, 080340389, 080439732, 080539750, 080539751, 080539752, 080539755, 080539756, 080539757, 080540101, 080540102, 080540103, 080540104, 080540105, 080540106, 080540107, 080540108, 080540109, 080540110, 080540111, 080540112, 080540113, 080540114, 080540115, 080541118, 080541119, 080541120, 080541121, 080541122, 080541123, 080541124, 080541125, 080541126, 080541127, 080541128, 080541129, 080541130, 080541131, 080541132, 080541163, 080541164, 080541165, 080541166, 080541167, 080541168, 080541169, 080541170, 080541171, 080541172, 080541173, 080541174, 080541175, 080541176, 080541177, 080541188, 080541189, 080541190, 080541223, 080541224, 080541225, 080541226, 080541227, 080541228, 080541229, 080541230, 080541231, 080541232, 080541233, 080541234, 080541235, 080541236, 080541237, 080541238, 080541239, 080740000, 080839665, 080839666, 080839667, 080940219, 080940220, 080940221, 080940598, 080940753, 080940754, 080940755, 080940756, 080940757, 080940758, 080940759, 081040840, 081040841, 081040842, 081040843, 081139364, 081139365, 081139366, 081139367, 081139368, 081139369, 081139370, 081139371, 081139372, 081139373, 081139374, 081139375, 081139376, 081139377, 081139378, 081139664, 081140082, 081140083, 081140084, 081140085, 090140100, 090140101, 090140102, 090140103, 090140104, 090140105, 090239555, 090239587, 090240122, 090240123, 090240124, 090240125, 090240126, 090240127, 090240128, 090240129, 090240130, 090240131, 090240132, 090240133, 090240134, 090240135, 090240136, 090240137, 090240138, 090240139, 090240140, 090240141, 090240488, 090240988, 090240989, 090240990, 090240991 and 090240992.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution - Colorado, Ohio, Wisconsin, and Germany, Italy, Netherlands, Poland and Switzerland.
  • Description du dispositif
    Stryker Medical Stair-PRO Stair Chair with wheels and a track system, patient transport device, Model 6252.
  • Manufacturer
    Stryker Medical Div. of Stryker Corporation

Manufacturer

Stryker Medical Div. of Stryker Corporation
  • Adresse du fabricant
    Stryker Medical Div. of Stryker Corporation, 3800 East Centre Ave., Portage MI 49002
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA