Events

Rappel de Device Recall Stryker InTouch Critical Care Bed

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
    49610
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0940-2009
  • Date de mise en oeuvre de l'événement
    2009-01-05
  • Date de publication de l'événement
    2009-02-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-11-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73918
  • 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
    ELECTRIC ICU BED; MULTIPLE - Product Code FNL
  • Cause
    The touch screen on the footboard may display a "tilt over range" error, resulting in a precautionary stop of the bed motions which result in the bed appearing to have locked out some of its bed positioning features.
  • Action
    Consignees were notified of the problems via letter dated January 5, 2009, advised to check their beds and to take them out of service if the foot board touchscreen displayed a "tilt over range" error, and that a Stryker Medical field service representative would contact them to perform software upgrades on the affected beds. Please direct questions to Stryker Medical at 1-269-324-6644.

Device

Device Recall Stryker InTouch Critical Care Bed
  • Modèle / numéro de série
    Serial Numbers: T02152, T02196, T02197, T02198, T02199, T02200, T02201, T02202, T02203, T02204, T02205, T02206, T02207, T02208, T02209, T02210, T02211, T02212, T02213, T02214, T02215, T02216, T02217, T02218, T02219, T02220, T02221, T02222, T02223, T02224, T02225, T02226, T02227, T02228, T02229, T02230, T02231, T02232, T02233, T02234, T02235, T02236, T02237, T01905, T01906, T01907, T01908, T01909, T01910, T01911, T01912, T01913, T01914, T01915, T01916, T01917, T01918, T01919, T01920, T01921, T01922, T01923, T01924, T01925, T01926, T01927, T01928, T01929, T01930, T01931, T01699, T01948, T01949, T01950, T01951, T01952, T01953, T01954, T01955, T01956, T01957, T01958, T01959, T01960, T01961, T01962, T01963, T01964, T01965, T01966, T01967, T01682, T01683, T01684, T01685, T01686, T01687, T01688, T01689, T01543, T01608, T01609, T01718, T01719, T01720, T02075, T02076, T02077, T02239, T02174, T01310, T01721, T01722, T01723, T02011, T02012, T02013, T02014, T02015, T02016, T02058, T02059, T02060, T02061, T02062, T02063, T02064, T02065, T01335, T01336, T01337, T01338, T01339, T01340, T01341, T01342, T01343, T01344, T01345, T01346, T01347, T01348, T01321, T01322, T01323, T01324, T01325, T01326, T01327, T01328, T01329, T01330, T01331, T01332, T01610, T01611, T01612, T01613, T02513, T02514, T02515, T01661, T01662, T01663, T01664, T01665, T01525, T01526, T01384, T01385, T01386, T01387, T01388, T02506, T02507, T02508, T02509, T02510, T02511, T02512, T02066, T02067, T02068, T01370, T01371, T01372, T01373, T01374, T01375, T01376, T01377, T01572, T01368, T01369, T02166, T02167, T02168, T02169, T02170, T02171, T02172, T02173, T01156, T01547, T01548,  T01696, T01552, T01553, T01554, T01555, T02175, T02176, T02177, T02178, T02179, T02180, T02090, T02088, T01546, T01544, T02087, T01698, T02089, T01551, T01697, T01545, T01550 and T01695.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution including USA and countries of Canada, Japan and Switzerland.
  • Description du dispositif
    Stryker InTouch 1.0 Critical Care Bed (Model 2130) with the Integrated PositionPro mattress (Model 2920) option. || The device is intended to be used as an Intensive Care Unit bed.
  • 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