Events

Rappel de Welch Allyn Vital Signs Monitor 5300 Series 300 || Part numbers 007-0098-00 through 007-0159-00

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 Welch Allyn Protocol, 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
    29233
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1333-04
  • Date de mise en oeuvre de l'événement
    2004-06-08
  • Date de publication de l'événement
    2004-08-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2006-06-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33369
  • 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
    Oximeter - Product Code DQA
  • Cause
    Potential speaker failure could result in absence of audible annunciation of pulse tones, patient alarms and equipment alerts.
  • Action
    The firm contacted their customers and their distributors customers via letters dated June 8, 2004 through July 9, 2004. The letters instruct their customers to verify speaker functionality. If the customers do not hear two quick beeps or there is static then they have a faulty speaker. The letters instruct them to stop using the monitor and contact Welch Allyn to have the monitor repaired. If the monitor continues to emit two quick beeps their customers are to contact Welch Allyn to have the monitor repaired as soon as it is convenient. The customers are to verify the two beeps prior to each use. The letter dated June 8, 2004 went to only a couple of direct customers. The remaining letters dated June 14, 2004, June 23, 2004, June 30, 2004 and July 9, 2004 went to direct customers, distributors and distributors'' end user customers.

Device

Welch Allyn Vital Signs Monitor 5300 Series 300 || Part numbers 007-0098-00 through 007-0159-00
  • Modèle / numéro de série
    Serial numbers JA000225 through JA002052.
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Welch Allyn distributes product to hospitals, physicians and distributors nationwide and internationally.
  • Description du dispositif
    Welch Allyn Vital Signs Monitor 5300 Series 300 || Part numbers 007-0098-00 through 007-0159-00
  • Manufacturer
    Welch Allyn Protocol, Inc

Manufacturer

Welch Allyn Protocol, Inc
  • Adresse du fabricant
    Welch Allyn Protocol, Inc, 8500 SW Creekside Pl, Beaverton OR 97008-7107
  • Source
    USFDA