Events

Rappel de Device Recall Horizon Cardiology ECG Management

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 McKesson Provider Technologies - Medical Imaging Group.

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
    57436
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0900-2011
  • Date de mise en oeuvre de l'événement
    2010-06-16
  • Date de publication de l'événement
    2011-01-13
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-08-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96241
  • 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
    Computer, diagnostic, programmable - Product Code DQK
  • Cause
    When importing ecg files from mortara ecg carts using dicom interface, the horizon cardiology ecg management system does not display the amplitudes of the waveform properly.
  • Action
    McKesson Medical sent an advisory notice letter dated June 16, 2010, to all affected customers. Advisory notice ADV01646 was distributed to 13 affected clinical sites from August 30, 2010 to September 28, 2010. The letters identified the product that is affected, the circumstances under which patient safety issue may occur, the risk, and the immediate actions that need to be taken along with a temporary fix. Customers were instructed to use the ECG cart printout to verify results of procedures acquired by Mortara ECG carts. Users should be aware of the problem when referrring to past ECG procedures and when performing a visual comparison with ECG procedures acquired by Mortara ECG carts. Customers should disable the Glasgow Serial Comparison for ECG procedures. McKesson Support would contact the customer to coordinate the deployment of the software update on all the affected applications and Horizon Cardiology client applications. For any questions regarding this recall, customers should call the Customer Support department at 1-866-777-0202 and speak to their Support Manager.

Device

Device Recall Horizon Cardiology ECG Management
  • Modèle / numéro de série
    K061905; Versions 12, 12 SP1, 12 SP1 HF2, 12 SP1 HF4, 12.1, 12.1 HF1, 12.1 HF2
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including AZ, CA, FL, GA, MA, PA, UT, and WI.
  • Description du dispositif
    Horizon Cardiology ECG Management || This is a software application designed for use in various hospital departments to import, display, store, analyze, distribute, and process ECG procedures from resting ECG devices. It is also intended to provide analysis or reanalysis or testings ECGs and to provide preliminary data for editing and confirmation by an over-reading physician. Horizon Cardiology ECG Management may provide a serial comparison of ECG Data to facilitate the review of the patient's current ECG with previous ECG's of the same patient.
  • Manufacturer
    McKesson Provider Technologies - Medical Imaging Group

Manufacturer

McKesson Provider Technologies - Medical Imaging Group
  • Adresse du fabricant
    McKesson Provider Technologies - Medical Imaging Group, 1639 State Rt 10 Ste 100, Parsippany NJ 07054-4506
  • Société-mère du fabricant (2017)
    Mckesson Corporation
  • Source
    USFDA