Events

Rappel de Stryker Medical transport 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
    52229
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0277-2010
  • Date de mise en oeuvre de l'événement
    2009-08-10
  • Date de publication de l'événement
    2009-11-17
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-10-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82574
  • 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 brake/steer pedal may seize, resulting in the brakes not working.
  • Action
    Consignees were notified by letter dated August 10, 2009 that Stryker will contact them to upgrade the stretchers within 6 months. The recall was expanded in scope to include additional serial numbers by a second letter dated September 17, 2009, which was issued to additional consignees who had not been previously notified of the recall, as well as the consignees who had been issued the August 10, 2009 letter.

Device

Stryker Medical transport stretcher
  • Modèle / numéro de série
    Serial numbers 0804103191, 0804103192, 0804103193, 0804103194, 0804103195, 0804103196, 0804103197, 0804103198, 0804103199, 0804103200, 0804103201, 0804103202, 0804103203, 0804104321, 0804104322, 0804104323, 0804104324, 0804104325, 0804104326, 0804104374, 0804105901, 0804105902, 0804105903, 0804105904, 0804105905, 0804105906, 0804105907, 0804105908, 0804105909, 0804105910, 0804105911, 0804105912, 0804105913, 0804105914, 0804105915, 0805099507, 0805099508, 0805099509, 0805101711, 0805101712, 0805101713, 0805101714, 0805101715, 0805101716, 0805101717, 0805101718, 0805101719, 0805101720, 0805101721, 0805101722, 0805101723, 0805101724, 0805101981, 0805101982, 0805101983, 0805101984, 0805101985, 0805101986, 0805101987, 0805101988, 0805101989, 0805101990, 0805101991, 0805101992, 0805101993, 0805101994, 0805101995, 0805101996, 0805101997, 0805101998, 0805101999, 0806099631, 0806099632, 0806099633, 0806099634, 0806099635, 0806099636, 0806099637, 0806099638, 0806099639, 0806099640, 0806099641, 0806099642, 0806099643, 0806099644, 0806099645, 0806099698, 0806099699, 0806099700, 0806101641, 0806101642, 0806101643, 0806101644, 0806101645, 0806101646, 0806101647, 0806101713, 0806101714, 0806101715, 0806101716, 0806101717, 0807103688, 0807103689, 0807103731, 0807103732, 0807103733, 0807103734, 0807103735, 0807103736, 0807103737, 0807103738, 0807103739, 0807103740, 0807103741, 0807103742, 0807103743, 0807103744, 0807103745, 0807108409, 0808100984, 0808100985, 0808100986, 0808100987, 0808100988, 0808105151, 0808105152, 0808105153, 0808105154, 0808105155, 0808105156, 0808105157, 0808105158, 0808105159, 0808105160, 0808105161, 0808105162, 0808105163, 0808105164, 0808105165, 0808105166, 0808105167, 0808105168, 0808106551, 0808106552, 0808106553, 0808106554, 0808106555, 0808106556, 0808106557, 0808106558, 0808106559, 0808106560, 0808106561, 0808106562, 0808106563, 0808106564, 0808106565, 0808106571, 0808106572, 0808106573, 0808106574, 0808106575, 0808106576, 0808106577, 0808106578, 0808106579, 0808106580, 0810105201, 0810105202, 0810105203, 0811101373, 0812102621, 0812102622, 0812102623, 0812102624, 0812102625, 0812102626, 0812102627, 0812102628, 0812102629, 0812102630, 0812102731, 0812102732, 0812102733, 0812102734, 0812102735, 0812102736, 0812102737, 0812102738, 0901032081, 0901032082, 0901032083, 0901032084, 0901032085, 0901032086, 0901032087, 0901032088, 0901032981, 0901032982, 0901032983, 0901032984, 0901032985, 0901032986, 0901032987, 0901032988, 0901032989, 0901032990, 0901032991, 0901032992, 0901032993, 0901032994, 0901032995, 0902030031, 0902030032, 0902030033, 0902030034, 0902030035, 0902030036, 0902030371, 0902030372, 0902030373, 0902030374, 0902030375, 0902030376, 0902030377, 0902030378, 0902030379, 0902030380, 0902032821, 0902032822, 0902032823, 0902032824, 0902032825, 0902032826, 0902032827, 0902032828, 0902032829, 0903034667, 0903034668, 0903034669 and 0903034670.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide, Argentina, Australia, Brazil, Canada, Chile, China, France, Germany, Greece, India, Italy, Japan, Korea, Latin America, Malaysia, Mexico, Netherlands, Philippines, Poland, Portugal, Singapore, South Africa, Spain, Switzerland, Taiwan, and United Kingdom,
  • Description du dispositif
    Stryker Medical transport stretcher, Stryker Medical, Portage, MI; Model 734. || Wheeled hospital stretcher.
  • 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