Events

Rappel de Health o Meter Professional

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 Pelstar, Llc.

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
    60031
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0294-2012
  • Date de mise en oeuvre de l'événement
    2011-10-07
  • Date de publication de l'événement
    2011-11-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-11-30
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104272
  • 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
    Scale, stand-on, patient - Product Code FRI
  • Cause
    There is a potential for an electrical short when installing or replacing the batteries in the remote display head of the scales. this short may cause the batteries to smoke, burn or burst.
  • Action
    Pelstar LLC. sent a Urgent Device Recall letter dated October 7, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter informed them of the potential of an electrical short caused when installing or replacing the batteries which may result in minor injuries to the person installing the batteries. The customers were requested to immediately examine their inventory and quarantine all product subject to the recall. In addition, if they distributed this product to end users, they were requested to identify all customers and notify them of this product recall at once in writing, using the enclosed recall notification letter. The customers were also requested to complete and return the enclosed mandatory response form as soon as possible. Any questions were directed to Health O Meter Professional at 800-815-6615 or 708-377-0600.

Device

Health o Meter Professional
  • Modèle / numéro de série
    Model 498KL, UPC Code - 892076002718, Serial numbers 4980000001 through 4980002909
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA (nationwide) including the countries of Canada, New Zealand, Israel and Lebanon.
  • Description du dispositif
    Health o Meter Professional Remote Display Digital Physician Scale, Model 498KL; digital patient weighing scale; Pelstar LLC, 11800 South Austin Avenue, Unit B, Alsip, IL 60803, U.S.A., Made n China; Model 498KL || Model 498KL scale with remote display head uses sophisticated microprocessor technology. Each instrument is designed to provide accurate, reliable and repeatable weight measurements and features that make the weighing process simple, fast and convenient. The scale is set up to determine the weight of a stationary patient. The weight can be displayed in pounds or kilograms. The unit can be operated by an AC adaptor (optional) or by 6-AA cell batteries (included).
  • Manufacturer
    Pelstar, Llc

Manufacturer

Pelstar, Llc
  • Adresse du fabricant
    Pelstar, Llc, 11800 S Austin Ave, Unit B, Alsip IL 60803-3559
  • Société-mère du fabricant (2017)
    Pelstar Llc
  • Source
    USFDA