Events

Rappel de Device Recall Stryker stretcher

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
    37978
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1009-2007
  • Date de mise en oeuvre de l'événement
    2007-05-07
  • Date de publication de l'événement
    2007-09-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2008-06-11
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=52574
  • 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 - Product Code FPO
  • Cause
    The internal power cord may become damaged due to wear and, if this occurs, a shock hazard exists.
  • Action
    Consignees were notified of the problem via letter dated 5/7/07 instructing them to immediately unplug the affected stretchers with scales, affix a warning label enclosed with the letter to the power cord of stretchers with scales, and that they will be contacted so that the firm can schedule a visit to upgrade all affected stretchers. A second notification letter was issued on August 7, 2007 to cover all 1550 stretchers with and without scales.

Device

Device Recall Stryker stretcher
  • Modèle / numéro de série
    Serial numbers 0508083666, 0509069531, 0509069532, 0509069533, 0509069534, 0509069535, 0509069542, 0509069564, 0509069565, 0509069566, 0509069567, 0509069568, 0509069569, 0509069588, 0509069589, 0509069590, 0509069591, 0509069662, 0509069663, 0509069664, 0509069665, 0509069693, 0509069694, 0509069695, 0509069696, 0509069697, 0509069698, 0509069699, 0509069700, 0509069701, 0509069770, 0509069771, 0509069772, 0509069773, 0509069774, 0509069775, 0509069776, 0509069777, 0509069778, 0509069795, 0509069796, 0509069806, 0509069816, 0509069817, 0509069818, 0509069819, 0509069832, 0509069835, 0509069836, 0509069837, 0509069838, 0509069839, 0509069840, 0509069841, 0509069848, 0509069849, 0509069873, 0509069874, 0509069875, 0509069876, 0509069877, 0510071024, 0510071025,  0510071026, 0510071032, 0510071033, 0510071034, 0510071035, 0510071036, 0510071037, 0510071038, 0510071039, 0510071040, 0510071041, 0510071042, 0510071043, 0510071154, 0510071155, 0510071156, 0510071157, 0510071158, 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  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide: USA, Latin America, Mexico and Spain.
  • Description du dispositif
    Stryker Medical -Wheeled Electric Stretcher, Model 1550 (with and without scales)
  • Manufacturer
    Stryker Medical Div. of Stryker Corporation

Manufacturer

Stryker Medical Div. of Stryker Corporation
  • Adresse du fabricant
    Stryker Medical Div. of Stryker Corporation, 3800 E. Centre Ave., Portage MI 49002
  • Source
    USFDA