Events

Rappel de Device Recall Shape HF Cardiopulmonary System

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 Shape Medical Systems, 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
    68581
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2051-2014
  • Date de mise en oeuvre de l'événement
    2014-05-28
  • Date de publication de l'événement
    2014-07-14
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-05-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128263
  • 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
    Calculator, predicted values, pulmonary function - Product Code BTY
  • Cause
    Shape medical has initiated a correction due to a mandatory software upgrade for the shape hf cardiopulmonary testing system prior to use of the impacted dpi lot numbers. use of the incorrect software version with the impacted dpis could result in erroneous testing results potentially leading to incorrect diagnosis and incorrect treatment.
  • Action
    Shape Medical Systems sent an Urgent Medical Device Correction letter dated June 17, 2014, to all affected customers. Customers were informed that new orders of the Disposable Patient interface devices (DPI) will require a software upgrade for the Shape HF Cardiopulmonary Testing System prior to using the new DPIs. Impacted DPIs will be shipped with Instructions to conduct the software upgrade and Technical Service will contact customers shipped the impacted DPIs to confirm receipt and assist with the software upgrade. A Response Form was requested to be returned. Customers with questions were instructed to call Shape Technical Service at 1-888-906-6266 or 651-621-2990.

Device

Device Recall Shape HF Cardiopulmonary System
  • Modèle / numéro de série
    DPIs with Lot Number 1405006 and higher.
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Shape HF Cardiopulmonary System. Made up of Shape HF System Analyzer (PN 0001-9001) and Disposable Patient Interface (DPI), (PN 0004-4001). A pulmonary gas exchange testing system used during cardiopulmonary exercise testing where collection and review of gas exchange variables are indicated. The system will provide physiological data to physicians to aid in patient assessment.
  • Manufacturer
    Shape Medical Systems, Inc

Manufacturer

Shape Medical Systems, Inc
  • Adresse du fabricant
    Shape Medical Systems, Inc, 5000 Township Pkwy, Saint Paul MN 55110-5852
  • Société-mère du fabricant (2017)
    Shape Medical Systems Inc.
  • Source
    USFDA