Events

Rappel de Device Recall P3700 Affinity Four Birthing 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 Hill-Rom, Inc..

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
    74760
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2750-2016
  • Date de mise en oeuvre de l'événement
    2016-07-15
  • Date de publication de l'événement
    2016-09-08
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-03-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148397
  • 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
    Table, obstetric (and accessories) - Product Code KNC
  • Action
    Hill-Rom Inc. initiated a voluntary recall of the Affinity Four Birthing Beds on July 15, 2016, with letters to customers mailed certified via FedEx. Customers were asked to do the following: During use, if you encounter a situation where the CPR mechanism fails to activate, the head of the bed can still be lowered, electrically, using the siderail articulation controls. A Hill-Rom representative will be contacting each facility to make arrangements for replacing the affected head drive. Please pass this notice on to all those who need to be aware within your organization and/or to any organization where the affected devices have been transferred. If you have any questions concerning this correction, please contact Hill-Rom Technical Support at 800-445-3720.

Device

Device Recall P3700 Affinity Four Birthing Bed
  • Modèle / numéro de série
    Affected Bed Lot Numbers: R062AA7482 R064AA7505 R042AA7318 R041AA7300 R062AA7483 R064AA7506 R042AA7320 R041AA7302 R062AA7484 R027AA7180 R042AA7321 R041AA7303 R046AA7345 R036AA7274 R042AA7323 R041AA7305 R039AA7278 R041AA7308 R042AA7324 R039AA7279 R039AA7276 R036AA7263 R039AA7281 R046AA7337 R039AA7275 R039AA7284 R046AA7346 R039AA7277 R063AA7503 R053AA7396 R061AA7475 R061AA7471 R053AA7400 R039AA7283 R061AA7472 R053AA7402 R039AA7285 R061AA7473 R053AA7404 R040AA7286 R061AA7474 R042AA7319 R039AA7282 R043AA7325 R046AA7342 R040AA7287 R043AA7327 R050AA7395 R040AA7289 R043AA7328 R056AA7443 R040AA7290 R043AA7329 R061AA7477 R040AA7292 R046AA7336 R040AA7291 R040AA7293 R046AA7339 R040AA7295 R040AA7294 R046AA7338 R041AA7301 R040AA7288 R063AA7492 R041AA7304 R040AA7296 R063AA7493 R041AA7307 R040AA7297 R063AA7494 R041AA7309 R042AA7322 R063AA7495 R041AA7310 R043AA7326 R063AA7496 R041AA7311 R043AA7330 R063AA7497 R041AA7312 R043AA7331 R063AA7498 R042AA7313 R043AA7332 R063AA7501 R042AA7314 R043AA7333 R063AA7502 R042AA7315 R041AA7298 R064AA7504 R042AA7316 R041AA7299
  • Classification du dispositif
    Obstetrical and Gynecological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution to the states of : CA, FL, IN, KS, LA, MI, MO, NC, NY, OK, OR, PA, TN, TX, WA, WY Foreign:BULGARIA, INDIA, UNITED ARAB EMIRATES
  • Description du dispositif
    Affinity Four Birthing Bed Model P3700 || The primary packaging is pictured below, and utilizes a metal packing brace, standard corrugated cardboard and plastic banding. When possible these beds are shipped as a quantity of two (2) together as shown with the nylon strapping. These are shipped in standard freight containers. There is no secondary packaging.
  • Manufacturer
    Hill-Rom, Inc.

Manufacturer

Hill-Rom, Inc.
  • Adresse du fabricant
    Hill-Rom, Inc., 1069 State Road 46 E, Batesville IN 47006-7520
  • Société-mère du fabricant (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA