Events

Recall of Intesys Clinical Suite (ICS) G2 92810 Smart Disclosure.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Spacelabs Healthcare, Incorporated.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    50226
  • Event Risk Class
    Class 2
  • Event Number
    Z-2270-2010
  • Event Initiated Date
    2008-10-17
  • Event Date Posted
    2010-08-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-09-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75007
  • Notes / Alerts
    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.
  • Extra notes in the data
    Programmable Diagnostic Computer - Product Code DQK
  • Reason
    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.
  • Model / Serial
    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.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US, Turkey, Chile, Brazil, Netherlands, Puerto Rico, Switzerland, Australia, Czech Republic, Canada, Italy, Singapore, France, Germany, and Israel.
  • Product Description
    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
  • Manufacturer Address
    Spacelabs Healthcare, Incorporated, 5150 220th Ave Se, Issaquah WA 98029-6834
  • Source
    USFDA