Events

Rappel de Device Recall SmartMonitor 2 PS/PSL

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 Circadiance 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
    77176
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2250-2017
  • Date de mise en oeuvre de l'événement
    2017-05-01
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-02-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155172
  • 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
    Material, embolization, neurovascular, polymerizing or precipitating - Product Code NPE
  • Cause
    Circadiance has determined that it is possible for certain smart monitor 2ps/psl monitors to exhibit intermittent operation of the nurse call feature. the firm has updated the device to increase the "nurse call" feature to ensure monitor alarms are transmitted to compatible nurse call systems.
  • Action
    Circadiance mailed a Medical Device Removal SmartMonitor 2 PS/PSL, dated 04/28/2017, to affected customers to inform them of the issue, the actions to be taken and the actions the firm plans to take to correct the issue. Customers are told to test the functionality of the system prior to each use; and, complete the Business Reply Form. The form can be returned via 412-202-4583 or emailed to james.gianoutsos@circadiance.com. Customers are to contact Circadiance Customer Service at 724-858-2837 to receive an Return Material Authorization number; or, 1-888-825-9640 to repair their unit free of charge, or for questions or support.

Device

Device Recall SmartMonitor 2 PS/PSL
  • Modèle / numéro de série
    Unique Device Identifier (UDI) 1030271, 1038140, 1038141, U1030271, and U1038140.  All serial numbers of units with "REF", "MODEL" or standalone part number 1030271, 1038140, 1038141, U1030271 or U1038140 located on the products label are impacted by this notice. Monitors with the above part numbers that have a serial number starting with "CP" are NOT affected by this issue.
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution.
  • Description du dispositif
    SmartMonitor 2 PS/PSL, Monitor, Apnea, Facility USE. || Intended for use in the continuous monitoring of respiration, heart rate, and SP02 of infant, pediatric and adult patients.
  • Manufacturer
    Circadiance LLC

Manufacturer

Circadiance LLC
  • Adresse du fabricant
    Circadiance LLC, 1060 Corporate Ln, Export PA 15632-8905
  • Société-mère du fabricant (2017)
    Circadiance LLC
  • Source
    USFDA