Events

Rappel de Device Recall Spacelabs Smart Disclosure System, Model 92810

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, 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
    63931
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0694-2013
  • Date de mise en oeuvre de l'événement
    2012-12-05
  • Date de publication de l'événement
    2013-01-17
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-07-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115067
  • 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
    Displaying or printing of an incorrect waveform for the time indicated in the printout or display in the spacelabs healthcare intesys clinical suite (ics) g2, version 4.03, clinical access portion of smart disclosure, model 92810.
  • Action
    Spacelabs has sent the Urgent -Medical Device Correction Spacelabs Healthcare ICS G2 Version 4.03 Model 92810 Smart Closure letter, dated 19 December 2012, to all U.S. customers. The firm plans to send a customer letter (translated as necessary) via e-mail to all international subsidiaries and distributors of record on December 27, 2012. The letter is addressed to Hospital Administrator/Biomedical Manager/Office Manager. Users are advised on the following actions: 1) Advise your staff of this potential failure and advise them to always click the "Refresh" button when scrolling to new waveform data prior to printing or viewing waveform information or storing saved events. 2) We will contact you at the earliest possible date to schedule a convenient time for your hospital to upgrade your affected software at no cost. Customers with questions can contact Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical Support.

Device

Device Recall Spacelabs Smart Disclosure System, Model 92810
  • Modèle / numéro de série
    ICS G2 Smart Disclosure Model 92810, Version 4.03.  There are no serial numbers.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA including Puerto Rico and the states of California, Florida, Iowa, Illinois, Louisiana, Michigan, Minnesota, North Carolina, South Carolina, Texas, and Washington, and the countries of Argentina, Mexico, France, and India.
  • Description du dispositif
    Spacelabs Smart Disclosure System, Model 92810, is an integrated component of the Intesys Clinical Suite (ICS) G2, Version 4.03. || 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. || The Spacelabs Smart Disclosure System, Model 92810 is indicated for use in clinical situations where there is a need for review of physiological waveform information and alarm events up to 72 hours after the fact. Smart Disclosure is also indicated in those situations where a retrospective analysis of monitoring patients' ECG waveform data, that can be annotated and edited, is desired. The intended use of the Spacelabs Smart Disclosure is to interface with the Spacelabs monitoring network, providing the user with a means of recalling waveform information and performing retrospective analysis. The most recent 72 hours of monitored patient ECG waveform data can be analyzed, with each analysis limited to 24 hours or less.
  • Manufacturer
    Spacelabs Healthcare, Llc

Manufacturer

Spacelabs Healthcare, Llc
  • Adresse du fabricant
    Spacelabs Healthcare, Llc, 5150 220th Ave Se, Issaquah WA 98029-6834
  • Société-mère du fabricant (2017)
    OSI Systems Inc
  • Source
    USFDA