Events

Rappel de Device Recall Tabs Professional Voice Monitor, Model 25223

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 Stanley Security Solutions, 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
    61796
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2492-2012
  • Date de mise en oeuvre de l'événement
    2012-05-04
  • Date de publication de l'événement
    2012-09-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-09-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109112
  • 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
    Monitor, bed patient - Product Code KMI
  • Cause
    The monitor may fail to sound an alarm.
  • Action
    Stanley Security Solutions, Inc. sent an Important Recall Notice dated May 4, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately cease using any of the affected product. The customers were informed, however, that they may continue to use the units as long as they were powered with a 9-volt alkaline battery in accordance with current instructions because the issue only occurs when using the 12V DC adaptor. The letter also informs the consignee to expect a follow-up notice no later than 6/1/12 that will provide additional instructions. The recalling firm issued additional letters dated 6/5/12 to distributors and end users with updated instructions. The letter informed them further testing revealed the possibility that a subset of affected monitors may also fail to alarm when powered by a 9V battery if weight is rapidly applied and removed from the pressure pad. Therefore, the recalling firm decided to recall and repair this subset of affected monitors and provided the serial number ranges that must be returned for repair. The letter also provided a list of serial number ranges that could be corrected in the field by permanently blocking access to the 12V DC jack on the monitor. Instructions were enclosed to show the customer how to disable to the jack. In addition the distributor letters request the customer to provide the recall information to their downstream customers. A response form was included to report the amount of affected product in the customers' inventory. For questions customers were instructed to call 888-224-2460. For questions regarding this recall call 407-271-2097.

Device

Device Recall Tabs Professional Voice Monitor, Model 25223
  • Modèle / numéro de série
    Serial numbers 236348 thru 347416
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Canada and Great Britain.
  • Description du dispositif
    Tabs Professional Voice + Monitor, with wire bracket, Model 25223. Stanley Security Solutions, Inc., Lincoln, NE. || Designed to help reduce the risk of falls by alerting caregivers when a resident is leaving a bed, chair, room or wheelchair.
  • Manufacturer
    Stanley Security Solutions, Inc.

Manufacturer

Stanley Security Solutions, Inc.
  • Adresse du fabricant
    Stanley Security Solutions, Inc., 4600 Vine St, Lincoln NE 68503-2823
  • Société-mère du fabricant (2017)
    Stanley Black & Decker Inc.
  • Source
    USFDA