Events

Rappel de Intesys Clinical Suite (ICS) G2 92810 Smart Disclosure.

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 Spacelabs Healthcare, Incorporated.

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
    50226
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2270-2010
  • Date de mise en oeuvre de l'événement
    2008-10-17
  • Date de publication de l'événement
    2010-08-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-09-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75007
  • 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
    Programmable Diagnostic Computer - Product Code DQK
  • Cause
    Potential for device to print out the wrong waveform data for the time indicated in the printout or display.
  • Action
    On 07/17/2008, Spacelabs Healthcare began sending the MEDICAL DEVICE CORRECTION letter to their consignees. The letter informs the consignees that there is an issue involving ICS G2 Smart Disclosure (Model 92810) which causes the display or printing of an incorrect waveform for the time indicated in the printout or display. The consignees are advised whether to discontinue to use the device until the firm upgrades the system. If the consignees decide to continue to use the device, then they should discontinue any use of the "Refresh" button. When they print or view waveform reports,t hey should utilize the Saved Event view functionality of the product rather than Arrhythmia, Alarm or Waveform Views. If the printing from the Arrhythmia, Alarm, or Waveform views, the consignees must visually inspect the print out and verify that the waveform contains what you expected to see printed. The consignees could contact Spacelabs Healthcare at 1-800-522-7052 or 1-425-657-7200, x5089 for any questions about the corrective actions of the affected device. The firm's field service engineer will make a schedule a mutually agreeable time with the consignees to update the ICS G2 system at free of charge.

Device

Intesys Clinical Suite (ICS) G2 92810 Smart Disclosure.
  • Modèle / numéro de série
    Software version V04.00.02 was shipped on 06/30/2008.  The 92810 is a software application installed on an off-the-shelf computer and is not serialized. Spacelabs uses software versions and ship dates for identification and traceability purposes.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- US, Turkey, Chile, Brazil, Netherlands, Puerto Rico, Switzerland, Australia, Czech Republic, Canada, Italy, Singapore, France, Germany, and Israel.
  • Description du dispositif
    Intesys Clinical Suite (ICS) G2 92810 Smart Disclosure. The Smart Disclosure product collects patient waveforms, alarms, vital signs and 12-lead reports. A 24-hour waveform acquisition is standard, with an upgrade option to 72 hours. || The product provides basic trends in both tabular and graphical format, along with a retrospective ECG analysis. The analysis may be defined by patient, and the data may be presented in multiple formats, including a rhythm, a histogram, and a summary view. || Standard reports are available from Smart Disclosure, including saved events, disclosure, trends histogram and summary.
  • Manufacturer
    Spacelabs Healthcare, Incorporated

Manufacturer

Spacelabs Healthcare, Incorporated
  • Adresse du fabricant
    Spacelabs Healthcare, Incorporated, 5150 220th Ave Se, Issaquah WA 98029-6834
  • Source
    USFDA